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Rejuvenate Total Hip System Surgical Protocol Rejuvenate Modular Hip Stem Enhanced Stability 1 Proven Modularity 2 Intraoperative Flexibility

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Rejuvenate Total Hip SystemSurgical Protocol

Rejuvenate Modular Hip Stem• Enhanced Stability1• Proven Modularity2• Intraoperative Flexibility

William N. Capello, M.D.Indiana University School of MedicineIndianapolis, INJames P. Crutcher, M.D.Swedish Medical CenterSeattle, WAJames A. D’Antonio, M.D.University of PittsburghPittsburgh, PA,Graham N. Gitlin, M.D.Cedars Sinai Medical CenterLos Angeles, CAKenneth A. Greene, M.D.Northeastern Ohio University College of MedicineRootstown, OH

Joseph J. Jankiewicz, M.D.Sharps-Reely HospitalSan Diego, CAJames Kudrna, M.D., PhDUniversity of ChicagoPritzker School of MedicineChicago, ILMichael A. Masini, M.D.St. Joseph Mercy HospitalAnn Arbor, MIJoseph C. McCarthy, M.D.Massachusetts General HospitalBoston, MAPhillip O. Merritt, M.D.Glendale Adventist Medical CenterGlendale, CA

Lawrence G. Morawa, M.D.Oakwood HospitalDearborn, MIJoseph P. Nessler, M.D.St. Cloud HospitalSt. Cloud, MNJames Scott, M.D.Tifton General HospitalTifton, GABrett R. Smith, M.D.Allegheny General Hospital Pittsburgh, PADaniel Ward, M.D.New England Baptist HospitalChestnut Hill, MA

Table of Contents

Indications, Contraindications, & Precautions .............................. 1System Overview .............................................................................. 1Preoperative Planning and X-Ray Evaluation ................................ 2Identifying the Proximal Femoral Shaft Axis .................................. 2Step 1 – Femoral Neck Resection...................................................... 2Step 2 – Preparing The Femoral Canal ...................................... 3-4Step 3 – Broaching the Femur............................................................ 5Step 4 – Calcar Planing .................................................................... 6Step 5 – Trial Reduction Off Broach .............................................. 6Monolithic Stem Option ................................................................ 6Modular Stem Option...................................................................... 7Step 6 – Stem Implantation ................................................................ 8

Step 7 – Trial Reduction Off Stem .................................................. 9Modular Stem Option Only .................................................... 9-11Step 8 – Neck and Head Implantation .......................................... 12Appendix A – Options: Modular Neck Extraction .................... 14Appendix B – Options: Stem Extraction ...................................... 14Appendix C – Modular Instrument Component Diagram ...... 14Appendix D – Implant Catalog Numbers and Stem Lengths .... 15Appendix E – Offset Chart and Acceptable Head/Neck

Combination Tables ................................................ 16Appendix F – Instrument Catalog Numbers .............................. 17Appendix G – Neck Implant Decision Algorithm ...................... 19Appendix H – Component Compatibility .................................... 20

This publication sets forth detailed recommended procedures for using Stryker® Orthopaedics devices and instruments. It offers guidance that you should heed, but,as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required.

Rejuvenate Total Hip System

Surgical Protocol

Surgeon Contributors:

1

Preoperative TemplatingThe Rejuvenate Femoral Platform includes a complete set of bothacetate (120% magnification) and digital femoral templates.

Acetabular OptionsStryker offers a wide variety of acetabular components that arecompatible with the Rejuvenate Total Hip System. The surgeonshould refer to the specific acetabular component’s surgical tech-nique for a discussion of acetabular surgical procedures.

Surgical ApproachesEach surgeon should use the surgical approach for total hiparthroplasty with which he or she is most familiar. Patient posi-tioning, prepping and draping, the skin incision, soft tissuedissection, and hip dislocation are performed according to thesurgeon’s preferred technique, making certain to adequatelyexpose the acetabulum and the proximal femur. The RejuvenateTotal Hip System accommodates most well-established surgicalapproaches.

IndicationsThe indications for use of total hip replacement prosthesesinclude:

1)noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

2)rheumatoid arthritis

3)correction of functional deformity;

4)revision procedures where other treatments or devices have failed; and,

5)treatment of nonunion, femoral neck and trochantericfractures of the proximal femur with head involvement that are unmanageable using other techniques.

6)Stryker’s REJUVENATE Modular Hip System is intendedfor cementless use only.

ContraindicationsAbsolute contraindications include:

1)overt infection;

2)distant foci of infections (which may cause hematogenous spread to the implant site);

3)rapid disease progression as manifested by joint destructionor bone absorption apparent on roentgenogram;

4)skeletally immature patients; and,

5)cases where there is a loss of abductor musculature,poor bone stock, or poor skin coverage around the hip joint which would make the procedure unjustifiable.

Conditions presenting increased risk of failure include:

1)uncooperative patient or patient with neurologic disorders, incapable of following instructions;

2)osteoporosis;

3)metabolic disorders which may impair bone formation; and,

4)osteomalacia.

Patients should be warned of these contraindications and risks.See the package insert for warnings, precautions, adverse effectsand other essential product information.

System OverviewThe Rejuvenate Femoral Platform is a modular primary hipsystem of femoral stems and necks that provide surgeons withoptions for personalizing the implant to each patient’s anatomyand biomechanical needs. The fixation philosophy is built uponthe clinically successful Stryker hip stems. The Rejuvenatefemoral stem represents the latest evolution in the OmniFit andSecur-Fit product lines, which has a successful published clinicalhistory.3

The Rejuvenate stem bodies are made of TMZF alloy, a propri-etary Stryker material with a plasma sprayed coating ofcommercially pure (CP) titanium and PureFix HA. The modularnecks are made of CoCr alloy.

The Rejuvenate femoral instrumentation consists of unique hipinstruments. The design of the Rejuvenate instrumentation incor-porates suggestions and feedback from an esteemed panel oforthopaedic surgeons, as well as key staff members from theoperating room (OR) and central supply.

The broach contours the proximal femur to the geometry of thestem to provide a complimentary fit of the stem to the bone. Thebroaches are designed with a series of teeth that are intended toseat against highly densified cancellous bone for the interferencepress-fit in the uncemented application.

2

Preoperative Planning and X-Ray EvaluationPreoperative planning aids in the selection of the most favorableimplant style and size for the patient’s hip pathology. Optimalfemoral stem fit, prosthetic neck length, angle and version canbe more closely evaluated with the use of preoperative x-rayanalysis. The following parameters should be determined usingan A/P radiograph:

Stem SizeFemoral OffsetLeg LengthNeck AngleCenter of Rotation

Determination of the probable implant size can facilitate oper-ating room preparation and assure availability of an appropriatesize selection. Preoperatively, an x-ray with analysis markingscan be valuable in identifying the appropriate neck resectionlevel (see below). Anatomic anomalies that could prevent theintra-operative achievement of the established preoperativegoals may also be detected.

The Pelvic Alignment Level (PAL) is an optional, single use,sterile hip position reference system that is available for useduring THR. The use of the PAL (cat. no. PAL-400) aids thesurgeon to recognize and understand the impact of intraopera-tive pelvic motion, and is designed to optimize acetabularalignment, reduce the chance for post-operative dislocationand restore femoral leg length and offset.

The Resection Guide has a threaded hole in the center thatallows attachment to the modular Head and Neck Impactorshaft to facilitate use in a small operative field.

1

2

Tip

Trochanteric Fossa

ProximalFemoralAxis

Scale onResection Guidecorresponds toscale on thetemplates

Using theResection Guideto determineresection pointbased on lessertrochanter

39° Neck resection angle

39°

1 Femoral Neck ResectionLay the Stryker Femoral Resection Guide (Figure 2) on thefemur, using the lesser trochanter and the trochanteric fossa aslandmarks when making the final cut. Care should be taken toalign the axis line of the Neck Resection Guide to the center axisof the femoral shaft; the scales on the lateral flange or medialradius of the guide can be used to reference the greater or lessertrochanter respectively when making the final cut.

Identifying the Proximal Femoral Shaft AxisNeutral alignment of a straight stem design requires the identifi-cation and preparation of the proximal femoral shaft axis. Thetrochanteric fossa, a reliable landmark for identifying the proximalshaft axis, must be unobstructed during preparation to permittrue axial reaming (Figure 1).

3

3

4

2 Preparing The Femoral CanalRetraction of the gluteus medius and removal of a portion of themedial aspect of the greater trochanter will permit true axialintroduction of the instruments and prostheses. A Box Osteotomeis useful in removing bone from this area. Connect the BoxOsteotome attachment to the Modular Handle. Use a Mallet tostrike the end of the Modular Handle with careful controlledblows to remove remnants of the superior femoral neck andopen the medullary canal (Figure 3). Reposition the BoxOsteotome if further bone removal is desired. Disconnect theBox Osteotome attachment from the Modular Handle immediately after use.

Starter ReamerThe Starter Reamer can be used to enter the femoral canalthrough the trochanteric fossa. The Starter Reamer has a pointto facilitate entry and graduated markings along the shaft thatcorrespond to implant sizes.

Enter the canal with the Starter Reamer attached to either a T-handle or powered instrument. Place the Starter Reamer onthe exposed trochanteric fossa and proceed down into the shaftalong its axis to the appropriate depth. The Starter Reamershould be inserted such that the appropriate marking corre-sponding to the preoperatively selected stem size correlates tothe depth of the medial resection point (Figure 4).

Tip

A clear-out hole has been placed on the back of the BoxOsteotome that allows bone to be removed using a Curetteor other OR instruments in an action that does not requirea force to be directed at the cutting surface.

Tip

Depth markings on the Starter Reamer, which correspondto the Tapered Reamer depth for each stem, should bealigned with the medial aspect of the resection plane.

MedialResectionPoint

12

ReamerDepth

10-118-9

6-754

4

Trochanteric ReamingSelect and use the appropriate Trochanteric Reamer to removelateral proximal cortical bone. This will further assist in estab-lishing proper axial alignment.

The Trochanteric Reamer is available in standard and large sizes.The Reamer should be inserted to a depth such that the distalend of the cutting flutes aligns with the medial resection point(Figure 5). Each Trochanteric Reamer is designed to prepare forthree stem sizes. See Table 1.

Broach Only OptionThe fully toothed Broaches may facilitate preparation of thefemoral canal without the use of Tapered Reamers. However, anarrow/tight diaphyseal shaft (e.g. champagne flute femur) mayresult in broach resistance in the distal canal. If resistance isencountered, tapered reaming is recommended to minimizepotential for distal femoral fractures. If the Broach does not seatat the desired height, ream upward until the Broach seats at thedesired height. The option to skip any reaming step is at thediscretion of the surgeon. Proceed to the next page for instructions on broaching.

Tapered ReamingImplant size is determined through templating and broaching.Reamers are used to prepare the canal distally where dense corticalbone exists, thereby aiding in broaching. Ream sequentiallyupward to one size under the templated size (Figure 6).

Note that although final implant size will be determined viabroaching, the last Tapered Reamer should be equal to orsmaller than the final implant. See Table 2 for a list of recom-mended Reamer sizes for each stem.

5

6

Stem Size Tapered Reamer5 5 - 66 5 - 67 7 - 88 7 - 89 9 - 1010 9 - 1011 11 - 1212 11 - 12

Table 2: Recommended Tapered Reamer Sizes

Stem Size Tapered Reamer7 - 9 Standard Trochanteric Reamer10 - 12 Large Trochanteric Reamer

Table 1: Recommended Trochanteric Reamer Sizes

MedialResectionPoint

Size 7

Size 8

Tip

If preoperative templating results in an in-between size,ream to smaller size.

Option

For Sizes 4-6, the standard Trochanteric Reamer is optionaland to be used according to surgeon’s discretion.

Caution

Reamers are sharp and aggressive.

Note

For size 4, Starter Reamer acts as Tapered Reamer.

5

3 Broaching The Femur

Assemble the Broach to the Broach Handle by inserting thealignment tab on the distal end of the Broach Handle into theBroach (Figure 7). Closing the locking arm until an audible clickis heard secures the Broach onto the Broach Handle.

Using a Mallet with short, controlled strokes, begin broachingand sequentially broach up until the desired size is reached.Throughout broaching, continue to apply lateral pressure toensure neutral alignment of the implant.

Correct fit will be denoted by a change in pitch or tactile resist-ance. To verify a secure fit, attempt to rotate the Broach relativeto the femur. With proper cortical contact, the Broach shouldnot twist or move relative to the femur. If there is movement, a larger size broach may be needed.

The final Broach should seat tightly in the femoral canal. TheBroaches are designed to seat to the same level as the implant,allowing neck trialing to be performed directly off of the Broach.However, it may be preferable to trial directly off of theimplanted stem.

The Rejuvenate Broaches and Stems are designed to produce apress-fit gradient (Figure 9). This approach to press-fit designallows for easier insertion, while enabling initial stability of thestem. Once optimal fit is achieved, remove the Broach Handleand proceed to Step 4.

7

8

9

Tip

The Stem Impactor can also be used with the Broach Handleto serve as a version guide (Figure 8). The fitting end of theStem Impactor is inserted into the top hole in the BroachHandle. The Stem Impactor can be held in place whileholding the Broach Handle. Alternately, the ModularHandle can be connected to the Stem Impactor/Version Barfitting to provide greater torsional control.

Optional

Trial reduction can be performed using the Broaches.However, it is recommended that for the Modular Implants,trial reduction be performed with the Modular Implant tomaximize procedure accuracy.

Caution

Proper insertion depth of the Broach in the canal is achievedwhen it seats tightly within the canal based on visual andauditory clues. The surgeon’s clues to firm implant fixationinclude increased pitch of sound with blows to BroachHandle and increased resistance to advancement. Relianceonly on the neck cut may lead to improper sizing, inade-quate component fixation, and femoral fracture.

Note

Regular lubrication of Broach Handle is recommended.

Locking Arm

Alignment Tab

QuickReleaseButton

Locking Hook

Broach

0.125mm press-fit per side

Press-fit gradient toend of Plasma Sprayregion

Line to line

6

4 Calcar Planing

Calcar planing creates a final resection plane and angle to optimizestem fit. There are two Calcar Planers in the set (standard, large).Select the size that fits the cut surface of the neck. Each CalcarPlaner includes a spring-loaded alignment tab that providescontrolled alignment and engagement with the Broach (Figure 10).Align the tab within the Broach body, initiate power and pressdown to plane the calcar to desired level.

5 Trial Reduction Off Broach

Monolithic Stem OptionThere are three monolithic Rejuvenate Stem sizes offered.Trialing is performed off the Broach with the appropriate Neckand Head Trials. Select the appropriate 0° Neck Trial, based on the pre-operativeplan and templating (refer to Table 3). The 0° Neck Trial islabeled with the following information:On the end of the trunnion:

0° version degreeArrow indicating neck angle directionBlack color coding dot

On the inferior and superior surfaces:The neck angle marking facing superiorly represents theangle in useNeck length

Snap the V40 Head Trial onto the Neck Trial. Perform trialreduction. After identifying the appropriate head and neck,remove the Head and Neck Trials from the Broach. Monolithic Stem Guidelines

For body size 4, do not use femoral head offset greater than+8mm.For body size 5, do not use femoral head offset greater than+12mm.For body size 6, do not use femoral head offset greater than+12mm.Table 3 lists the permissible stem/neck and head combina-tions for the Monolithic Stems.Use contrary to these specifications will negate the responsi-bility of the device manufacturer.

Broach RemovalAttach the Broach Handle to the Broach and extract using aMallet. Proceed with stem insertion and final trial reduction (See Step 6).

10

11

Alignment Tab

Calcar Planer

VersionDegrees

127 °

132°

127 °

132°

Neck AngleDirection

Neck Angle

ColorCoding

Neck Trial

Note

If neck angle direction arrow points superiorly #, neck angleis 132° as shown on superior neck angle marking. If neckangle direction arrow points inferiorly $, neck angle is 127°as shown on superior neck angle marking.

4566

Monolithic Stem

Table 3: Monolithic Stem Neck and Head Trial Choices

NeckLength

26mm26mm26mm30mm

Neck Angle

132°132°132°127°

MaximumFemoral Head Offset

Max Head and NeckCombinedLength

Face of Neck Trial

Stem Size

+8mm+12mm+12mm+12mm

34mm38mm38mm42mm

Note

Calcar Planer removes less than 4mm of bone. Bone remnantscan be removed from the Calcar Planer to continue calcarplaning.

Note

Regular lubrication of Calcar Planers is recommended.

Note

Size 6 is the only monolithic stem available with 127° neckangle.

Caution

Failure to operate the Calcar Planer in accordance with theinstructions above may result in damage to the femur.

Neck Angle 132°

Neck Angle 127°

7

Modular Stem OptionSelect a Neck Trial, based on the pre-operative plan andtemplating (refer to Decision Algorithm in Appendix G). TheNeck Trial is labeled with the following information:On the end of the trunnion:

Version degreesArrow indicating version and neck angle directionColor coding dot indicating version

On the inferior and superior surfaces:The neck angle marking facing superiorly represents the anglein useNeck length

Once the neck length requirements are established, select a NeckTrial with the necessary version and varus/valgus orientation thatbest reproduces patient biomechanics based on the pre-operativeplan (refer to Neck Trial Option Chart on page 11). Insert theNeck Trial into the Broach (Figure 12). The Neck Trial will snapinto place. Snap the V40 Head Trial onto the Neck Trial. Performtrial reduction. After identifying the appropriate Head and Neck,remove the Head and Neck Trials from the Broach.

Modular Stem - Modular Neck & Modular Head Guidelines

Total Head & Neck Construct Length = Head Offset +Modular Neck Length.Table 4 below lists the permissible stem/neck and headcombinations. Appendix E lists permissible femoral headoffsets.Deviation from these specifications may affect the structuralintegrity of the neck-stem modular junction. Use contrary to these specifications will negate the responsibility of the device manufacturer.

Broach RemovalAttach the Broach Handle to the Broach and extract using a Mallet.Proceed with stem insertion and final trial reduction (See Step 6).

Refer to Appendix E for Acceptable Head/Neck combinations andAppendix H for Component Compatibility.

* Achieved only by combining a Modular Neck with a head offsetgreater than +0mm.

Tip

Keep the last Neck Trial that was used captured in the NeckTrial Forceps. This will allow a secondary method ofconfirming the desired neck implant.

Note

If neck angle direction arrow points superiorly #, neck angle is132° as shown on superior neck angle marking. If neck angledirection arrow points inferiorly $, neck angle is 127° asshown on superior neck angle marking.

VersionDegrees

127 °

132°

127 °

132°

VersionDirection

ColorCoding

12Neck Trial

Face of Neck Trial

Neck Angle 132°

Neck Angle 127°

Neck AngleDirection

Neck Angle

Table 4: Max Total Head and Neck Construct Length per Version

Stem SizeVersion 7 8 9 10 11 120° 46* 46* 46* 46* 46* 46*8° 46* 46* 46* 46* 46* 46*16° 38 38 42 46* 46* 46*

Total Head &Neck Construct

Length

HeadOffset

NeckLength

= +

Total Head& Neck

ConstructLength

HeadOffset

ModularNeckLength

8

6 Stem Implantation

The Rejuvenate Femoral Platform offers two instrument optionsto insert the monolithic and modular stems (Figure 13):

Option 1: The Rejuvenate Stems all have an insertion feature thatconsists of a non-threaded hole with a version-control keyway onthe top surface of the proximal body. The Stem Inserter uses ametal collet that expands inside the insertion feature to form asecure connection with the stem facilitating stem insertion andversion control. To attach a stem, open the Stem Inserter'slocking arm completely, place tip of Inserter completely into theinsertion feature and ensure proper seating of the key in thekeyway. While holding the stem in position, close the lockingarm of the Inserter to the “closed” position as shown in (Figure13a).

Proceed with stem insertion while firmly griping the locking arm.Use a Mallet with short, controlled strokes to seat the implant.Typically, the final implant is seated when the proximal edge ofthe plasma spray is even with the resection level (Figure 13b).

Option 2: For surgeons who prefer off-axis stem impaction, theRejuvenate Femoral Platform also includes a modular StemImpactor. The Stem Impactor has unique distal geometrydesigned to allow impaction against the insertion feature. Toprepare the Impactor for use, attach to the Modular Handle.

Proceed with stem insertion. Use a Mallet with short, controlledstrokes to seat the implant. Typically, the final implant is seatedwhen the proximal edge of the plasma spray is even with theresection level (Figure 13b).

13a

13b

Option 2:Stem Impactor

StemImpactor

Do not exceed agreater than 30°impacting anglefrom the axis ofthe stem

ModularHandle

ResectionLevel

Option 1:Stem Inserter

LockingArm

Note

Prior to proceeding with stem implantation, the surgeonshould follow the standard procedure for femoral canal prepa-ration, including proper irrigation.

Note

Use of off-axis Stem Impactor could potentially alter geom-etry of insertion feature, thus not allowing subsequent useof Stem Inserter on Modular Stem.

Note

Do not impact Stem Inserter if it is not completely seated inthe insertion feature. The Inserter is completely seated in thestem insertion feature when the face of the Inserter is flushwith the top surface of the stem body and the Inserter’sversion key is placed fully in the stem’s keyway.

Caution

The Stem Impactor does not capture the stem. Care shouldbe taken to prevent it from slipping off the stem anddamaging the trochanter. For best results, use shortcontrolled mallet strokes. Do not exceed an angle of 30°from the axis of the stem.

Caution

The surgeon should NOT attempt tocontinue impacting the femoralcomponent if visual and auditoryclues indicate that the resting positionof the femoral component has beenreached. This can be true even if thefemoral component is not yet down tothe level of the Broach. Continuedaggressive impaction may lead tofemoral fracture.

30°Max

127 °

132°

127 °

132°

9

7 Trial Reduction Off Stem

Modular Stem Option OnlyThe Rejuvenate stem is prepackaged with a Neck Trial Adapter.This Adapter provides an interface between the Stem and theNeck Trial. This Adapter remains in the Stem throughout trialreduction.Select a Neck Trial, based on the pre-operative plan andtemplating (refer to Decision Algorithm in Appendix G). The Neck Trial is labeled with the following information:On the end of the trunnion:

Version degreesArrow indicating version and neck angle directionColor coding dot indicating version

On the inferior and superior surfaces:The neck angle marking facing superiorly represents the angle in useNeck length

Once the neck length requirements are established, select a NeckTrial with the necessary version and varus/valgus orientation thatbest reproduces patient biomechanics based on the pre-operativeplan (refer to Neck Trial Option Chart on page 11). Insert theNeck Trial into the Adapter (Figure 14). The Neck Trial will snapinto place. Snap the V40 Head Trial onto the Neck Trial. Performtrial reduction. After identifying the appropriate Head and Neck,remove the Head and Neck Trials from the Adapter.

Modular Stem - Modular Neck & Modular Head Guidelines

Total Head & Neck Construct Length = Head Offset +Modular Neck Length.Table 4 below lists the permissible stem/neck and headcombinations. Appendix E lists permissible femoral headoffsets.Deviation from these specifications may affect the structuralintegrity of the neck-stem modular junction. Use contrary to these specifications will negate the responsibility of the device manufacturer.

14

Neck Angle 132°

Neck Angle 127° Version

Degrees

VersionDirection

ColorCoding

Neck AngleDirection

Neck Angle

Note

If neck angle direction arrow points superiorly #, neck angle is132° as shown on superior neck angle marking. If neck angledirection arrow points inferiorly $, neck angle is 127° asshown on superior neck angle marking.

Table 4: Max Total Head and Neck Construct Length per Version

Total Head &Neck Construct

Length

HeadOffset

NeckLength

Refer to Appendix E for Acceptable Head/Neck combinations andAppendix H for Component Compatibility.

* Achieved only by combining a Modular Neck with a head offsetgreater than +0mm.

Tip

Keep the last Neck Trial that was used captured in the NeckTrial Forceps. This will allow a secondary method ofconfirming the desired neck implant.

Stem SizeVersion 7 8 9 10 11 120° 46* 46* 46* 46* 46* 46*8° 46* 46* 46* 46* 46* 46*16° 38 38 42 46* 46* 46*

= +

Total Head& Neck

ConstructLength

HeadOffset

ModularNeckLength

Face of Neck Trial

Neck Trial

Modular Stem

Neck TrialAdapter

8°G38mmV40

8°G38mmV40

10

Neck Trial & Implant Labeling ConventionThe modular Neck Trials are stored in a color-coded caddy,organized by length, within the instrument set tray. Each Trialhas a color dot on the end of the trunnion to correspond to thecolor and description on the Neck Trial Caddy (Figure 15).

Once trial reduction is complete, the surgeon can request theappropriate Modular Neck using neck length and color code.This will provide sufficient information with which to identifythe correct implant.

On the package label is the Modular Neck catalog number. Thatnumber includes the implant length, the amount of version andthe color code letter. Once the package is opened and theModular Neck is removed, the implant is labeled on the trun-nion with taper type, implant length and amount of version aswell as arrows indicating version direction and neck angle.

The example at right demonstrates the labeling convention for a38mm Modular Neck with 132° neck angle and 8° of anteversionfor use in a right hip. This implant has the green color code(refer to Neck Trial Option Chart on page 11).

Neck Trial Adapter RemovalInsert the Adapter Removal tool into the Neck Trial Adapter andsqueeze the handle (Figure 16). Remove the Adapter from theStem and discard immediately.

Ensure that neither soft tissue nor any other material has enteredthe stem taper after removal of the Adapter, and prior to implan-tation of the Modular Neck. The Stem is now ready to receive aNeck Implant.

15

Neck Trial Caddy

GreenDot

Neck Trial NeckImplant

Neck AngleDirection

TrunnionTaper

“G”-Green

VersionDirection

8° Version

Neck Length

Catalog No. NLV-380800G

Face of Neck Implant

16

Neck Trial AdapterRemoval Tool

Caution

Do not apply torsional force to Adaptor during removal.

Note

The Adapter is radiopaque for visualization under X-ray.The Adapter is intended only for single-use. DO NOTattempt to reuse. If needed, adapters are available as single,sterile packaged pieces (cat. no. 1601-2000).

Neck Angle 132°

Neck Angle 127°

11

8°G30mmV40

8°G30mmV40

8°8°

8°G30mmV40

8°G30mmV40

8°8°

Retroverted

8°G30mmV40

8°G30mmV40

8°8°

8°G30mmV40

8°G30mmV40

8°8°

Illustration of Neck Trial andNeck Implant for Right / Left Hip

Right Hip Left Hip

16° RetroPurple

16° AntePurpleLeft Hip

132° 8° RetroGreen

132°0° NeutralBlack

132° 8° AnteYellow

127° 8° AnteGreen

127° 8° RetroYellow

127°0° Neutral

Black

16° RetroPurple

16° AntePurple

132° 8° RetroYellow

132°0° NeutralBlack

132°8° AnteGreen

127° 8° AnteYellow

127° 8° RetroGreen

127°0° Neutral

Black

Right Hip

Neck Trial Option Chart Neck Trial Caddy

Note

Four boxes above demonstrate how the Neck Trial and the Neck Implant can be used in the right and left hip.

Implant Trial

Anteverted

Face of Neck Trial

Right Hip132° Neck Angle8° Anteversion

Face of NeckImplant

Trial Implant

Right Hip127° Neck Angle8° Retroversion

Retroverted

Face of Neck Trial

Face of NeckImplant

Face of Neck Trial

Anteverted

Left Hip127° Neck Angle8° Anteversion Trial Implant

Face of NeckImplant

Left Hip132° Neck Angle8° Retroversion Trial Implant

Face of NeckImplant

Face of Neck Trial

12

8 Neck and Head Implantation

Attach the Modular Handle to the Neck and Head Impactor(Figure 17). The inside of the tip of the Neck and HeadImpactor is specially shaped to accept the trunnion of the Neck.Place the Modular Neck into the Modular Stem using the arrowsindicating neck angle and version angle as a guide. Impact theModular Neck into the Modular Stem. Two moderate Malletblows are sufficient. Impact the Head onto the Modular Neck.

If utilizing a Cobalt Chrome Head, select the appropriate sizeand place it onto the dry trunnion of the Femoral Stem with aslight twist. Impact the Head with two moderate blows using theNeck and Head Impactor.

If utilizing a BIOLOX delta ceramic Head, the appropriate size isintraoperatively assembled to the Neck and is seated with abouttwo moderate blows using the Neck and Head Impactor. Caremust be taken to avoid excessive impaction forces when assem-bling the ceramic Head to the Neck. Verify the Head is secure onthe trunnion after impaction. If necessary, the Head can beremoved utilizing the head disassembly instrument.*

Reduce the joint and closeRelocate the Femoral Head into the Acetabular Cup and checkthe stability and range of motion. The surgical site is then closedaccording to the standard procedure for the surgical approachchosen.

Postoperative carePostoperative care should progress according to surgeon prefer-ence and recommendation.

17ModularHandle

Neck andHead Impactor

* If a BIOLOX delta ceramic Head is placed on the trunnion andthen removed, it must be replaced with a V40 Cobalt Chromehead, a V40 Titanium Adapter Sleeve (17-0000E) and a C-Taperceramic Head or a V40 Universal Adapter Sleeve and a BIOLOXdeltaUniversal Taper ceramic Head.

A fully seated neck implantin the Modular Stem

Note

Neck and Head Impactor does not hold the Neck or Head.

Note

If Universal Head is selected, impact Modular Neck to Stembefore placing Universal Adapter Sleeve on Neck.

Note

Alumina ceramic femoral Heads cannot be used directly onthe Cobalt Chrome Modular Neck and require the use of aTitanium V40 Adapter Sleeve (17-0000E) to convert the V40stem trunnion to C-Taper.

After completing the trialing process, intra operativelyassemble the Adaptor Sleeve to the Femoral Stem manually.The Universal Adaptor Sleeve must be fully seated on the Stemtrunnion before the Head is assembled.

NOTE: In no instance should any attempt be madeto pre-assemble the Adaptor Sleeve inside theBIOLOX delta Universal Ceramic Head.

Intraoperatively assemble the BIOLOX deltaUniversal TaperCeramic Head onto the sleeved Femoral Stem and set withone to three moderate blows using the Stem Head Impactor(1104-1000). Care must be taken to avoid excessive impactforces when assembling the Ceramic Head to the sleevedfemoral component.

Table 5: Universal Adaptor Sleeves

Universal Adaptor Sleeve Stem MaterialPart Numbers Taper Compatibility

19-0XXXT C-Taper TMZF, Ti-6Al-4V, CoCr

6519-T-XXX V40 TMZF, Ti-6Al-4V, CoCr

OPTIONAL STEPNOTE: When selecting a BIOLOX delta UniversalTaper Ceramic Femoral Head for implantation withRejuvenate, use of a V40 Universal Adaptor Sleeveis necessary (Table 5).

13

APPENDICES

Table of Contents

Appendix A – Options: Modular Neck Extraction................................................................................................................................................ 14

Appendix B – Options: Stem Extraction ................................................................................................................................................................ 14

Appendix C – Modular Instrument Component Diagram ................................................................................................................................. 14

Appendix D – Implant Catalog Numbers and Stem Lengths .................................................................................................................................. 15

Appendix E – Offset Chart and Acceptable Head/Neck Combination Tables...................................................................................................16

Appendix F – Instrument Catalog Numbers ......................................................................................................................................................... 17

Appendix G – Neck Implant Decision Algorithm................................................................................................................................................. 19

Appendix H – Component Compatibility............................................................................................................................................................... 20

14

Appendix A Options: Modular Neck ExtractionThe Neck Implant is removed with the use of the Rejuvenate NeckExtractor (Figure 18). The Neck Implant is extracted by placingthe Neck Extractor under either the medial or lateral side of thebase of the Neck and levering out the Neck. Neck Trial Forcepsare recommended to capture the neck during extraction.

Appendix B Options: Stem Extraction

There are instruments to manage the extraction of a Monolithicor Modular Stem in both intraoperative and revision situations(Figure 19).

The Modular Stem Extractor uses a connection pin, which engagesthe stem insertion feature and a locking arm that engages theModular Stem taper. The arm is secured in place using a threadedlocking knob. The proximal end of the instrument attaches to aMcReynolds Extractor Assembly (6869-1-000, 6869-2-000, 6869-3-000) to provide the surgeon with a tool to facilitate the removalof a well-fixed Femoral Stem. The Modular Stem Extractorshould be reseated and retightened after four extraction blows.

The Monolithic Stem can be extracted with the McReynoldsDistal Stem Adapter (6260-4-090) and McReynolds Driver(6869-1-000, 6869-2-000, 6869-3-000) from the RestorationModular Instrument System.

19

Appendix C Modular Instrument Component Diagram

20

Box Osteotome

Stem ImpactorModular Handle

Head/NeckImpactor

LockingKnob

Tip

Tap end of Neck Extractor with a Mallet to remove Neck in acontrolled manner.

Tip

Ensure instrument is fully seated in the Modular Handlebefore use.

18

Neck TrialForceps Neck

Extractor

Neck Implant

Caution

Do NOT impact the Locking Knob of the Modular StemExtractor as this could damage it.

Note

The Stem Inserter should not be used to extract the Stem.

McReynolds Extractor Assembly

ModularStemExtraction

ExtractorLocking

Arm

ExtractorConnection

McReynoldsDistal StemAdapter

MonolithicStemExtraction

15

Appendix D Implant Catalog Numbers andStem Lengths

Monolithic Stems Cat. No.Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 4, 132° SPT-043100SRejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 5, 132° SPT-053200SRejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 6, 132° SPT-063400SRejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 6, 127° SPT-063800S

Modular Stems Cat. No.Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 7 SPT-070000SRejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 8 SPT-080000SRejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 9 SPT-090000SRejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 10 SPT-100000SRejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 11 SPT-110000SRejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 12 SPT-120000S

Modular Necks Cat. No.Rejuvenate Modular Neck, 30mm, 0°, 127°/132°, Black NLS-300000BRejuvenate Modular Neck, 30mm, 8° AV/RV, 127°/132°, Yellow NLV-300800YRejuvenate Modular Neck, 30mm, 8° RV/AV, 127°/132°, Green NLV-300800GRejuvenate Modular Neck, 30mm, 16° RV/AV, 130°, Purple NLS-301600PRejuvenate Modular Neck, 34mm, 0°, 127°/132°, Black NLS-340000BRejuvenate Modular Neck, 34mm, 8° AV/RV, 127°/132°, Yellow NLV-340800YRejuvenate Modular Neck, 34mm, 8° RV/AV, 127°/132°, Green NLV-340800GRejuvenate Modular Neck, 34mm, 16° RV/AV, 130°, Purple NLS-341600PRejuvenate Modular Neck, 38mm, 0°, 127°/132°, Black NLS-380000BRejuvenate Modular Neck, 38mm, 8° AV/RV, 127°/132°, Yellow NLV-380800YRejuvenate Modular Neck, 38mm, 8° RV/AV, 127°/132°, Green NLV-380800GRejuvenate Modular Neck, 38mm, 16° RV/AV, 130°, Purple NLS-381600PRejuvenate Modular Neck, 42mm, 0°, 127°/132°, Black NLS-420000BRejuvenate Modular Neck, 42mm, 8° AV/RV, 127°/132°, Yellow NLV-420800YRejuvenate Modular Neck, 42mm, 8° RV/AV, 127°/132°, Green NLV-420800GRejuvenate Modular Neck, 42mm, 16° RV/AV, 130°, Purple NLS-421600P

Table 6: Monolithic Stem, Modular Stem and Modular Neck Implants

Stem Size Stem Length (mm)4 1105 1156 1207 1308 1369 14210 14811 15512 160

Table 7: Stem Lengths

StemLength

16

Offset

Appendix E Offset Chart and AcceptableHead/Neck Combination Tables

Stem Size

30mm Neck Length0° Version132°37.7mm38.6mm39.8mm41.0mm42.0mm43.1mm

789101112

39.4mm40.3mm41.6mm42.7mm43.8mm44.9mm

37.4mm38.4mm39.6mm40.8mm41.8mm42.9mm

39.2mm40.1mm41.4mm42.5mm43.6mm44.7mm

127° 132° 127° 130°8° Version 16° Version

37.6mm38.6mm39.8mm41.0mm42.0mm43.1mm

Stem Size

Neck132°31mm32mm34mm

456

NANA38mm

127°

Stem Size

34mm Neck Length0° Version132° 127° 132° 127° 130°

8° Version 16° Version

Stem Size

38mm Neck Length0° Version132° 127° 132° 127° 130°

8° Version 16° VersionStem Size

42mm Neck Length0° Version132° 127° 132° 127° 130°

8° Version 16° Version

Table 8: Monolithic (Offset with +0mm head)

Tables 9-12: Modular (Offset with +0mm head)

46.3mm47.2mm48.4mm49.6mm50.6mm51.7mm

48.7mm49.6mm50.9mm52.0mm53.1mm54.2mm

N/AN/A48.7mm49.9mm50.9mm52.0mm

49.0mm50.0mm51.2mm52.3mm53.4mm54.5mm

46.6mm47.5mm48.7mm49.9mm50.9mm52.0mm

Table 14: Head and Neck Combination*

* Not all offsets are available in all materials or all diameters. The table includes C-taper and V40 offset head options. Use of the C-taper head requires the assembly of a Titanium Adapter Sleeve (17-0000E) to convert the V40 stem trunnion to C-taper.See Appendix H for information on Component Compatibility for modular heads and acetabular components.

† 16° version not compatible with sizes 7 & 8 ‡ 16° version not compatible with size 9

43.6mm44.5mm45.7mm46.9mm48.0mm49.0mm

45.8mm46.7mm48.0mm49.1mm50.2mm51.3mm

43.3mm44.2mm45.5mm46.6mm47.7mm48.8mm

45.5mm46.5mm47.7mm48.8mm49.9mm51.0mm

789101112

789101112

40.6mm41.6mm42.8mm44.0mm45.0mm46.1mm

42.6mm43.5mm44.8mm45.9mm47.0mm48.1mm

40.4mm41.3mm42.5mm43.7mm44.7mm45.8mm

42.3mm43.3mm44.5mm45.7mm46.7mm47.8mm

40.6mm41.6mm42.8mm43.9mm45.0mm46.1mm

789101112

43.6mm44.5mm45.7mm46.9mm48.0mm49.0mm

Stem Size

46mm Total Head and Neck Length0° Version132° 127° 132° 127° 130°

8° Version 16° Version

49.5mm50.5mm51.7mm52.9mm53.9mm55.0mm

52.2mm53.2mm54.4mm55.6mm55.6mm57.7mm

49.2mm50.1mm51.4mm52.5mm53.6mm54.7mm

51.9mm52.8mm54.0mm55.2mm56.2mm57.3mm

789101112

N/AN/AN/A52.9mm53.9mm55.0mm

Top View

Modular NeckImplant -5mm

✔ ✔

✔ ✔

✔ ✔

✔ ✔

-4mm

✔†

-2.7mm

✔†

-2.5mm

✔†

+0mm

✔†

✔†‡

+2.5mm

✔†

✔†‡

+3mm

✔†

✔†‡

+4mm

✔†

✔†‡

+5mm

✔†

✔†‡

+7.5mm

✔†

✔†‡

+8mm

✔†

✔†‡

+10mm

✔†

✔†‡

+12mmFemoral Head Offsets*

30mm

34mm

38mm

42mm

Note

Tables above may not be an exhaustive list of all femoral head options inall materials.

Table 13: Max Achievable Offset (Achieved only bycombining a Modular Neck with a head offset greater than +0mm)

Table 4: Max Total Head and Neck Construct Length per Version

* Achieved only by combining a Modular Neck with a head offsetgreater than +0mm.

Stem SizeVersion 7 8 9 10 11 120° 46* 46* 46* 46* 46* 46*8° 46* 46* 46* 46* 46* 46*16° 38 38 42 46* 46* 46*

17

Appendix F Instrument Catalog Numbers

Table 15: Rejuvenate Primary Instruments

Cat. No. Description1601-1600 Rejuvenate Stem Inserter1601-1650* Rejuvenate Modular Stem Extractor1601-1690 Rejuvenate Stem Impactor1601-1700 Rejuvenate Head/Neck Impactor1601-1801 Rejuvenate Neck Extractor1601-1100* Rejuvenate Broach Handle1601-1900 Rejuvenate Adaptor Removal Tool1440-1700 Offset Neck Trial Forceps1101-2200 Orthonomic T-Handle1020-2900 Orthonomic Modular Handle1601-2526 Rejuvenate 26 mm, 0 Degree Neck Trial

127/132 Degree Black1601-2530 Rejuvenate 30 mm, 0 Degree Neck Trial

127/132 Degree Black1601-2534 Rejuvenate 34 mm, 0 Degree Neck Trial

127/132 Degree Black1601-2538 Rejuvenate 38 mm, 0 Degree Neck Trial

127/132 Degree Black1601-2542 Rejuvenate 42 mm, 0 Degree Neck Trial

127/132 Degree Black1601-2630 Rejuvenate 30 mm, 8 Degree Neck Trial

AV/RV 127/132 Degree Yellow1601-2634 Rejuvenate 34 mm, 8 Degree Neck Trial

AV/RV 127/132 Degree Yellow1601-2638 Rejuvenate 38 mm, 8 Degree Neck Trial

AV/RV 127/132 Degree Yellow1601-2642 Rejuvenate 42 mm, 8 Degree Neck Trial

AV/RV 127/132 Degree Yellow

Rejuvenate Primary Instruments (continued)

Cat. No. Description1601-2730 Rejuvenate 30 mm, 8 Degree Neck Trial

RV/AV 127/132 Degree Green1601-2734 Rejuvenate 34 mm, 8 Degree Neck Trial

RV/AV 127/132 Degree Green1601-2738 Rejuvenate 38 mm, 8 Degree Neck Trial

RV/AV 127/132 Degree Green1601-2742 Rejuvenate 42 mm, 8 Degree Neck Trial

RV/AV 127/132 Degree Green1601-2830 Rejuvenate 30 mm, 16 Degree Neck Trial 130

Degree Purple1601-2834 Rejuvenate 34 mm, 16 Degree Neck Trial 130

Degree Purple1601-2838 Rejuvenate 38 mm, 16 Degree Neck Trial 130

Degree Purple1601-2842 Rejuvenate 42 mm, 16 Degree Neck Trial 130

Degree Purple1601-5010 Rejuvenate Neck Trial Caddy 26mm & 30mm1601-5011 Rejuvenate Neck Trial Caddy 34mm1601-5012 Rejuvenate Neck Trial Caddy 38mm1601-5014 Rejuvenate Neck Trial Caddy 42mm

Table 16: Trial Heads

Cat. No. Description6264-8-132R 32mm STD V40 Trial Head6264-8-136R 36mm STD V40 Trial Head

* Regular lubrication recommended. Refer to lubrication procedure,Literature LRJ-ISS.

Note

A total of 9 trial heads can be placed in the instrument tray.

18

Table 18: Rejuvenate Instrument Cases

Cat. No. Description1601-5000 Rejuvenate Instrument Case1601-5001 Rejuvenate Femoral Tray 11601-5002 Rejuvenate Femoral Tray 21601-5003 Rejuvenate Procedure Tray 11601-5004 Rejuvenate Procedure Tray 2

Cat. No. Description6260-4-090 McReynolds Distal Stem Adapter6869-1-000 Shaft, McReynolds Extractor Assembly6869-2-000 Driving Handle, McReynolds Extractor

Assembly6869-3-000 Sliding Hammer, McReynolds Extractor

Assembly

Table 19: Ancillary Extraction Instruments

Cat. No. Description1601-2000 Neck Trial Adapter (1 piece sterile)

Table 20: Miscellaneous

Appendix F Instrument Catalog Numbers(continued)

Cat. No. Description1601-1004A Rejuvenate Broach, Straight, size 41601-1005A Rejuvenate Broach, Straight, size 51601-1006A Rejuvenate Broach, Straight, size 61601-1007A Rejuvenate Broach, Straight, size 71601-1008A Rejuvenate Broach, Straight, size 81601-1009A Rejuvenate Broach, Straight, size 91601-1010A Rejuvenate Broach, Straight, size 101601-1011A Rejuvenate Broach, Straight, size 111601-1012A Rejuvenate Broach, Straight, size 121601-1210 Modular Box Osteotome1601-1300 Rejuvenate Neck Resection Guide1601-1310 Ruler1601-1400* Rejuvenate Calcar Planar, Standard1601-1420* Rejuvenate Calcar Planar, Large1601-1504 Rejuvenate Starter Reamer1601-1531 Rejuvenate Trochanteric Reamer, Standard1601-1532 Rejuvenate Trochanteric Reamer, Large1601-1556 Rejuvenate 2-for-1 Tapered Reamer, Size 5-61601-1578 Rejuvenate 2-for-1 Tapered reamer, Size 7-81601-1590 Rejuvenate 2-for-1 Tapered Reamer, Size 9-101601-1512 Rejuvenate 2-for-1 Tapered Reamer, Size 11-12

Table 17: Rejuvenate Femoral PreparationInstrumentation

* Regular lubrication recommended. Refer to lubrication procedure,Literature LRJ-ISS.

19

Appendix G Neck Implant Decision Algorithm

Choose Stem Angle Based on Patient Anatomy

127° or 132°

Choose Neutral (Black) Neck34mm*

Std. +0mm trial head (Black)

Trial Reduction Step #1 –Leg Length and Offset Assessment

Increase or Decrease Neck Length

Increase or Decrease Head Offset – Fine Tuning Options depend on head diameter and material

Trial Reduction Step #2 – Version Assessment

Flexion ImpingementUse 8

Anteverted neck†

ExtensionImpingement

Use 8 Retroverted neck†

† 16 version can also be used, butneck angle will change to 130°

* Suggested starting point – final selection should be based on surgeon’s discretion. Total head and neck construct length should follow guidelinesindicated in Appendix E.

Sizes 7, 8, 9

Choose Stem Angle Based on Patient Anatomy

127° or 132°

Choose Neutral (Black) Neck38mm*

Std. +0mm trial head (Black)

Trial Reduction Step #1 –Leg Length and Offset Assessment

Increase or Decrease Neck Length

Increase or Decrease Head Offset – Fine Tuning Options depend on head diameter and material

Trial Reduction Step #2 – Version Assessment

Flexion ImpingementUse 8

Anteverted neck†

ExtensionImpingement

Use 8 Retroverted neck†

† 16 version can also be used, butneck angle will change to 130°

Sizes 10, 11, 12

20

Appendix H Component Compatibility

Modular HeadsTable 21 includes a list of compatible Femoral Heads. See thepackage insert accompanying the specific component for theindications, contraindications, warnings, precautions and otherinformation regarding the use of the Head. Maximum offsetused may be restricted by Modular Stem body size and ModularNeck combinations. See Step 7 for Modular Stem-Modular Neck& Modular Head Guidelines for the appropriate combinations.

Additional Information for Constrained LinersConstrained Liners are intended for use in primary or revisionpatients at a high risk of hip dislocation due to a history of dislo-cation, bone loss, joint or soft tissue laxity, neuromuscular diseaseor intraoperative instability.

Constrained Liners are contraindicated in patients with thefollowing conditions: bone or musculature compromised bydisease, infection or prior implantation, which cannot provideadequate support or fixation for the prosthesis, infection in orabout the hip joint or skeletal immaturity.

See the package insert accompanying the Constrained Liner forthe indications, contraindications, warnings, precautions andother information regarding the use of the liner. See the surgicaltechnique of the specific liner for the steps to appropriatelyimplant the component.

Compatible Acetabular ComponentsThe compatible Heads may be used with compatible Strykerunipolar, bipolar and acetabular components. Table 22 includesa list of compatible acetabular components. See the packageinsert accompanying the specific component for the indications,contraindications, warnings, precautions and other informationregarding the use of the Head. See the individual surgical tech-niques for implantation of the acetabular components.

Compatible Acetabular ComponentsTrident X3 Acetabular Inserts Trident Crossfire Elevated Rim LinersTrident Crossfire Polyethylene Liners, 10º or 0º profileTrident Crossfire Eccentric Poly Liners, 10º or 0º profileTrident Poly Liners, 10º or 0º profileTrident Eccentric Poly LinersTrident Constrained InsertTrident All Poly Cup Trident Crossfire All Poly CupUnitrax Unipolar HeadUHR Bipolar HeadTrident N2/Vac Polyethylene InsertsTrident Hemispherical ShellsTrident Hemispherical HA ShellsTrident PSL HA ShellsTrident Tritanium ShellsTrident Alumina Insert used with a C-taper Alumina Head and a V40/C-taper Adapter SleeveRestoration ADM ShellsTritanium PSF Shells

Compatible Femoral Heads OffsetV40 BIOLOX delta -5mm to +7.5mm V40 LFIT CoCr -5mm to +12mmC-Taper Alumina* -5mm to +5mmV40/C-taper Adapter Sleeve

Table 21

Table 22

*Requires use of a Titanium V40 Adapter Sleeve (17-0000E) toconvert the V40 stem trunnion to C-Taper.

Compatible Ceramic Femoral Heads

Table 23: V40 Taper BIOLOX delta Ceramic HeadsCatalog Diameter Offset TrialNo. (mm) (mm) Catalog No.

6570-0-028 28 -4 6264-8-028R6570-0-328 28 -2.7 6264-8-928R6570-0-128 28 +0 6264-8-128R6570-0-228 28 +4 6264-8-228R6570-0-032 32 -4 6264-8-032R6570-0-132 32 +0 6264-8-132R6570-0-232 32 +4 6264-8-232R6570-0-036 36 -5 6264-8-036R6570-0-436 36 -2.5 6264-8-436R6570-0-136 36 +0 6264-8-136R6570-0-536 36 +2.5 6264-8-536R6570-0-236 36 +5 6264-8-236R6570-0-736 36 +7.5 6264-8-736R

Compatible Femoral Heads continued on next page.

Note

Tables above may not be an exhaustive list of all options inall materials.

Table 24: C-Taper BIOLOX delta Ceramic HeadsCatalog Diameter Offset TrialNo. (mm) (mm) Catalog No.

18-28-3 28 -2.5 1100-2897R18-2800 28 +0 1100-2800R18-2825 28 +2.5 1100-2825R18-2805 28 +5 1100-2805R18-32-3 32 -2.5 1100-3297R18-3200 32 +0 1100-3200R18-3225 32 +2.5 1100-3225R18-3205 32 +5 1100-3205R18-36-5 36 -5 1100-3699R18-36-3 36 -2.5 1100-3697R18-3600 36 +0 1100-3600R18-3625 36 +2.5 1100-3625R18-3605 36 +5 1100-3605R18-3675 36 +7.5 1100-3675R

Requires use of a Titanium V40 Adapter Sleeve (17-0000E) to convertthe V40 stem trunnion to C-Taper

21

Compatible Ceramic Femoral Heads (continued)

Compatible CoCr Femoral Heads

Table 29: V40 Taper LFIT HeadsCatalog Diameter Offset TrialNo. (mm) (mm) Catalog No.

6260-9-122 22 +0 6264-8-122R6260-9-222 22 +3 6264-8-222R6260-9-322 22 +8 6264-8-322R6260-9-026 26 -3 6264-8-026R6260-9-126 26 +0 6264-8-126R6260-9-226 26 +4 6264-7-226R6260-9-326 26 +8 6264-8-326R6260-9-426 26 +12 6264-8-426R6260-9-028 28 -4 6264-8-028R6260-9-128 28 +0 6264-8-128R6260-9-228 28 +4 6264-8-228R6260-9-328 28 +8 6264-8-328R6260-9-428 28 +12 6264-8-428R6260-9-032 32 -4 6264-8-032R6260-9-132 32 +0 6264-8-132R6260-9-232 32 +4 6264-8-232R6260-9-332 32 +8 6264-8-332R6260-9-432 32 +12 6264-8-432R

Table 30: V40 Taper LFIT Anatomic HeadsCatalog Diameter Offset TrialNo. (mm) (mm) Catalog No.

6260-9-036 36 -5 6264-8-036R6260-9-136 36 +0 6264-8-136R6260-9-236 36 +5 6264-8-236R6260-9-336 36 +10 6264-8-336R6260-9-040 40 -4 6264-8-040R6260-9-140 40 +0 6264-8-140R6260-9-240 40 +4 6264-8-240R6260-9-340 40 +8 6264-8-340R6260-9-440 40 +12 6264-8-440R6260-9-044 44 -4 6264-8-044R6260-9-144 44 +0 6264-8-144R6260-9-244 44 +4 6264-8-244R

Table 28: C-Taper Alumina Ceramic HeadsCatalog Diameter Offset TrialNo. (mm) (mm) Catalog No.

17-28-3E 28 –2.5 1100-2897R17-2800E 28 +0 1100-2800R17-2805E 28 +5 1100-2805R17-32-3E 32 –2.5 1100-3297R17-3200E 32 +0 1100-3200R17-3205E 32 +5 1100-3205R17-36-5E 36 –5 1100-3699R17-3600E 36 +0 1100-3600R17-3605E 36 +5 1100-3605R

Table 26: Universal Trial HeadsCatalog Diameter OffsetNo. (mm) (mm) Taper

6264-8-728R 28 -2.5 V406264-8-632R 32 -2.5 V406264-3-236R 36 +4.0 V406264-8-940R 40 -2.5 V406264-8-944R 44 -2.5 V40

Requires use of a Titanium V40 Adapter Sleeve (17-0000E) to convertthe V40 stem trunnion to C-Taper

Table 27: Universal Adapter Sleeves - Titanium

Catalog No. Offset (mm) Taper

6519-T-025 -2.5 V406519-T-100 +0 V406519-T-204 +4 V40

Note

Tables above may not be an exhaustive list of all options inall materials.

Table 25: Universal Taper BIOLOX delta Ceramic Heads

Catalog No. Diameter (mm)6519-1-028 286519-1-032 326519-1-036 366519-1-040 406519-1-044 44

Requires use of Universal Adapter Sleeve.

325 Corporate DriveMahwah, NJ 07430t: 201 831 5000

www.stryker.com

A surgeon must always rely on his or her own professional clinical judgment when deciding whether touse a particular product when treating a particular patient. Stryker does not dispense medical advice andrecommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon mustalways refer to the package insert, product label and/or instructions for use before using any Stryker product.Products may not be available in all markets because product availability is subject to the regulatory and/ormedical practices in individual markets. Please contact your Stryker representative if you have questions aboutthe availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for thefollowing trademarks or service marks: Accolade, Crossfire, LFIT, N2/Vac, OmniFit, PSL, PureFix, Rejuvenate,Restoration, Secur-Fit, Stryker, TMZF, Trident, Tritanium, UHR, Unitrax, V40, X3. All other trademarks are trademarks of their respective owners or holders.

Literature Number: LSP65 Rev.3MS/GS 07/11

Copyright © 2011 Stryker Printed in USA.

References1. Steppacher, S.D., Ecker, T.M., et al. Managing Length and Stability: The role of the modular neck.Orthopaedics, Vol.31, No.9, September 2008.

2. RD-07-027 Fatigue Performance of the Rejuvenate Modular Stem/neck construct under a modified ISO neck test model.

3. Capello, W., et al. Hydroxyapatite-coated Femoral Components, 15-Year Minimum Followup, CORR, Vol.453, December 2006:pp.75 - 80.