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Stryker Interventional Spine.

Your single source for VCF solutions.

Relieving pain. Improving lives.

Learn more about iVAS, our latest technology for VCFs.

StrykerIVS.com

Stryker Interventional Spine.Your single source for VCF solutions.


Literature Number: 1000-025-036 Rev NoneDDM/PSCopyright © 2010 StrykerPrinted in USA

Stryker Instruments4100 East Milham AvenueKalamazoo, MI 49001 USAt: 269 323 7700 f: 800 999 3811toll free: 800 253 3210www.stryker.com

The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Products referenced with TM designation are trademarks of Stryker. Products referenced with ® designation are registered trademarks of Stryker.

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Footnotes1. National Osteoporosis Foundation. Disease facts. Available at: www.nof.org/ osteoporosis/diseasefacts.htm. Accessed

September 11, 20092. Siemionow, K and Lieberman, IH. Vertebral Augmentation in Osteoporotic and Osteolytic Fractures. Current Opinion in

Supportive and Palliative Care. 2009 Sept 3:219-2253. http://www.orthosupersite.com/view.asp?rID=1702 accessed Sept. 11, 20094. Lovi A, Teli M, Ortolina A, et al. Vertebroplasty and Kyphoplasty: Complementary Techniques for the Treatment of Painful

Osteoporotic Vertebral Compression Fractures. A Prospective Non-randomised Study on 154 Patients Eur Spine Jour (2009) 18 (Suppl 1):S95-S101

5. Passias PG, Li Gang, Wood, KB. SRS Position Paper: The Results of Vertebral Augmentation Procedures Department of Orthopaedic Spine Surgery Massachusetts General Hospital and Harvard Medical School Boston, MA Sept. 8, 2008

6. Lavelle W, Carl A, Lavelle ED, Khaleel MA. Vertebroplasty and Kyphoplasty, Anesthesiol Clin. 2007 Dec;25 (4):913-287. McKiernan F, Faciszewski T, Jensen R. Quality Of Life Following Vertebroplasty. J Bone Joint Surg Am. 2004

Dec;86-A(12):2600-6 8. The Worldwide Orthopaedic Market. Prepared by Knowledge Enterprises. October 2005, p. 119. Orthopaedic Industry Annual Report: 2008-2009. Orthoworld, Inc. 2009, p. 2210. Kochan, J. Vertebroplasty and Kyphoplasty, Percutaneous. http://emedicine.medscape.com/article/423209- overview

Accessed September 1, 2009. 11. Wardlaw, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P,Talmadge K, Boonen

S. Efficacy and Safety of Balloon Kyphoplasty Compared with Non-surgical Care for Vertebral Compression Fracture (FREE): a Randomized Controlled Trial www.thelancet.com Published online February 25, 2009 DOI:10.1016/S0140-6736(09)60010-6

12. Jensen ME, McGraw JK, Cardella JF, Hirsch JA. Position statement on percutaneous vertebral augmentation: A consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. J Vasc Interv Radiol 2009; 20:S326–S331

13. Eck JC, Nachtigall D, Humphreys SC, Hodges SD. Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature. The Spine Journal 2008; 8:488-497

14. Percutaneous Vertebroplasty and Kyphoplasty – Ed. 2 / Editors, John M Mathis, Hervé Deramond, Stephen M. Belkoff. Copyright 2006 by Springer Science+Business Media, Inc., p. 118

* Information current as of August 1, 2010

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PCD (Sterile; 4 per box)

0505-582-00010g PCD System KitIncludes: One-half dose of SpinePlex Bone Cement, one PCD mixer and delivery system, one 10g 5" diamond tip match-ground introduction needle, one 10g 5" interchangeable bevel stylet


0505-585-00013g PCD System KitIncludes: One-half dose of SpinePlex Bone Cement,one PCD mixer and delivery system, one 13g 5" diamond tip match-ground introduction needle, one 13g 5" interchangeable bevel stylet

0505-586-000PCD System Kit with 90º Short Extension Tube and without NeedlesIncludes: One-half dose of SpinePlex Bone Cement, one PCD mixer and delivery system with 90º short extension tube

0505-587-000PCD System Kit without NeedlesIncludes: One-half dose of SpinePlex Bone Cement, one PCD mixer and delivery system

0505-589-000PCD System Kit with Straight Short Extension Tube and without NeedlesIncludes: One-half dose of SpinePlex Bone Cement, one PCD mixer and delivery system with straight short extension tube

0506-482-00010g PCD System Kit without CementIncludes: One PCD mixer and delivery system, one 10g 5" diamond tip match-ground introduction needle, one 10g 5" interchangeable bevel stylet

0506-483-00011g PCD System Kit without CementIncludes: One PCD mixer and delivery system, one 11g 5" diamond tip match-ground introduction needle, one 11g 5" interchangeable bevel stylet 0506-485-00013g PCD System Kit without CementIncludes: One PCD mixer and delivery system, one 13g 5" diamond tip match-ground introduction needle, one 13g 5" interchangeable bevel stylet

0506-486-000PCD System Kit without Cement or NeedlesIncludes: One PCD mixer and delivery system

0506-489-000PCD System Kit with Straight Short Extension Tube and without Cement or NeedlesIncludes: One PCD mixer and delivery system with straight short extension tube

0507-589-000VertaPlex HV / PCD System Kit with Straight Short Extension Tube and without NeedlesIncludes: One half dose of VertaPlex HV Bone Cement, one PCD mixer and delivery system with straight short extension tube

Bone Cements

VertaPlex HV Offered only with mixing devices. See Mixers and Delivery Systems below.

VertaPlex (Sterile; 2 per box)

0406-402-000 VertaPlex 20 Gram Twin Pack (one-half dose)

SpinePlex (Sterile; 2 per box)

0406-202-000 SpinePlex 20 Gram Twin Pack (one-half dose) 0406-200-000 SpinePlex 40 Gram Twin Pack (full dose)

iVAS Inflatable Vertebral Augmentation System

0705-115-00010g iVAS System Kit (Sterile; 3 per box)(2-15 mm) Includes: Balloon catheter, access cannula with diamond tip stylet, bevel tip stylet, locking syringe, inflater, stop cock

0705-115-50010g iVAS Balloon Catheter (Sterile; 3 per box)(2-15 mm) Á la Carte 0306-810-000 10g Hand Drill (Sterile; 6 per box)

Mixers and Delivery Systems

AutoPlex (Sterile; 2 per box)

0605-683-00011g AutoPlex System KitIncludes: One-half dose of VertaPlex Bone Cement, one AutoPlex mixer and delivery system, one 11g 5" diamond tip match-ground introduction needle


0605-687-000AutoPlex System Kit without NeedlesIncludes: One-half dose of VertaPlex Bone Cement, one AutoPlex mixer and delivery system

0605-887-000AutoPlex System Kit without Cement or Needles Includes: One AutoPlex mixer and delivery system

0607-687-000AutoPlex System Kit with VertaPlex HV without Needles Includes: One-half dose of VertaPlex HV Bone Cement, one AutoPlex mixer and delivery system

ACM Kits (Sterile; 4 per box)

0405-583-00011g ACM System KitIncludes: One full dose of SpinePlex Bone Cement, one ACM system, one luer lock nozzle, two 11g 5" diamond tip match-ground introduction needles, two bevel stylets, six 1cc syringes, two 3cc syringes


0405-584-000ACM System Kit without Needles or SyringesIncludes: One full dose of SpinePlex Bone Cement, one ACM system, one luer lock nozzle

0405-586-000ACM System Kit without NeedlesIncludes: One full dose of SpinePlex Bone Cement, one ACM system, one luer lock nozzle, six 1cc syringes, two 3cc syringes

VertePort

Access Cannulae (Sterile; 6 per box)

0306-400-000 10g 5.75" Long Stylet Access Cannula

0306-430-000 10g 5" Short Stylet Access Cannula

0306-110-000 11g 5" Diamond Tip Match-Ground Introduction Needle

Cement Cannulae (Sterile; 18 per box)

0306-510-000 11g Cement Cannula (for use with 11g 5" access needle 0306-110-000)

0306-410-000 10g Cement Cannula (for use with 10g long and short access needles 0306-400-000 and 0306-430-000)

Accessories0206-000-000 High Vacuum Pump

0206-500-000 Automatic High Vacuum Pump

0306-650-000 Percutaneous Cement Gun

Notes:

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Needles

(Sterile; 6 per box)

10g 0306-100-000 10g 5" Diamond Tip Match-Ground Introduction Needle

0306-101-000 14g 4" Bevel Tip Match-Ground Introduction Needle





0306-114-000 11g 4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet

0306-150-000 11g 5" Bevel Tip Stylet without Needle

13g 0306-134-000 13g 4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet




14g 0306-140-00014 g 4.4" Diamond Tip Match-Ground Introduction Needle and Bevel Stylet

Bone Biopsy Kits (Sterile; 6 per box)

0306-105-000 10g 5" Bone Biopsy Kit




To order, contact Stryker Instruments customer service at 800.253.3210. StrykerIVS.com

Osteoporotic fractures are a serious and growing problem for older adults and the healthcare system. In fact, one in two women and one in four men will have an osteoporotic fracture during their lifetime.1 Vertebral compression fractures (VCFs) are the most common with an estimated 700,000 such fractures reported nationally each year.2, 3


With the introduction of the iVAS Inflatable Vertebral Augmentation System, Stryker provides you multiple options for treating VCFs whether you’re performing percutaneous vertebroplasty or vertebral augmentation.

From iVAS to our mixer and delivery systems, cements, and needles,our unprecedented portfolio of products lets you customize yourtreatment approach. Stryker Interventional Spine’s innovative solutions are designed to work together seamlessly for ease of use and increased control, helping to provide enhanced procedural efficiency.

Trust Stryker Interventional Spine’s full portfolio of solutions designed to help you offer optimal patient care.

The benefit of choice. The advantage of Stryker.

Needle is guided into fractured vertebra using fluoroscopy

Vertebroplasty involves injection of bone cement directly into a fractured vertebral body from a percutaneous approach. The hardened cement stabilizes the fracture, relieving pain.4,5

Vertebral augmentation is a treatment option for vertebral compression fractures that creates a void in the cancellous bone by way of an inflated balloon. This procedure helps ensure controlled and contained cement delivery into the factured vertebral body. Clinical results for both procedures show substantial pain relief 2,6 in approximately 90% of patients6 and potentially a significant increase in quality of life.2,7

The balloon is inflated, compacting the trabeculae and creating a cavity

Balloon catheter is inserted into the fractured vertebra

Vertebral Augmentation

Once the balloon is deflated and withdrawn, the cavity is filled with bone cement

Stabilized vertebral body

Vertebroplasty

Bone cement is injected


Every spine is unique. Now your treatment options are too.

Vertebral compression fracture is identified

Hand drill is inserted into the anterior third of the vertebral body to create a pathway

Needle is guided into fractured vertebra using fluoroscopy

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Working

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Over the last three and a half decades, Stryker has implanted more than 23 million doses of bone cement. This expertise is grounded in Stryker’s Simplex® P Bone Cement. In 1971, Simplex P became the first surgical bone cement approved by the FDA for total hip replacement. For more than 40 years, tens of thousands of physicians have trusted Stryker bone cements derived from Simplex P including SpinePlex®, VertaPlex®, and now VertaPlex HV.


Graph 1. Independent lab results from Fluid Dynamics, Inc. commissioned by Stryker, Inc. July 2009. Testing conducted at 20-21˚C (68-70˚F).

1958

Simplex C Bone Cement introduced in Europe

1962

Simplex P Bone Cement introduced in Europe

1971

Simplex P first to receive FDA approval in the U.S. for total hip arthroplasty

1973

Simplex P Bone Cement approved for total knee arthroplasty

1975

Simplex antibiotic Bone Cement (with Erythromycin and Colistin) introducedin Europe

1976

Simplex P approvedfor pathological fractures and general prosthetic fixation

1999

Over 15 million doses of Simplex P have been implanted

2000

Simplex P with Tobramycinintroduced in Europe

2003

Simplex P with Tobramycinintroduced in U.S.

SpinePlex introducedin Europe

2004

SpinePlex introduced in U.S.and used in thousands of VCF cases worldwide

2008

VertaPlex introduced worldwide

2010

VertaPlex HV introduced worldwide

As one of the world’s leading manufacturers of bone cement, Stryker continues to set the industry standard by providing physicians with a range of bone cements that address specific viscosity and working time preferences for the treatment of vertebral compression fractures.

Stryker’s three unique VCF bone cements – compared at right – are indicated for use with percutaneous vertebroplasty and vertebral augmentation, providing the flexibility you want and the options you need for individualized patient care.

Once a benchmark, always a benchmark.

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Stryker Bone Cement Viscosity

Ready when you are.

VertaPlex HV is a high viscosity bone cement that contributes to improved visibility and control. VertaPlex HV reaches a thick viscosity as soon as it’s mixed and maintains its viscous state for an average of 18 minutes.

VertaPlex® HV Bone Cement VertaPlex® SpinePlex®

Ordering Information

0607-687-000 (Sterile; 2 per box)VertaPlex HV / AutoPlex System Kit without Needles Includes: One-half dose of VertaPlex HV bone cement, one AutoPlex mixer and delivery system

0507-589-000 (Sterile; 4 per box)VertaPlex HV / PCD System Kit with Straight Short Extension Tube and without NeedlesIncludes: One-half dose of VertaPlex HV bone cement, one PCD mixer and delivery system with straight short extension tube

A la carte

0406-402-000 (Sterile; 2 per box)VertaPlex 20 Gram Twin Pack (One-half Dose) 0406-202-000 (Sterile; 2 per box)SpinePlex 20 Gram Twin Pack (One-half Dose)

0406-200-000 (Sterile; 2 per box)SpinePlex 40 Gram Twin Pack (Full Dose)

Recommended Companion Products

VertaPlex HV

• AutoPlex

• PCD(shorttube)

• VertePort

• AllNeedles&CementCannulae

VertaPlex

• AutoPlex

• PCD

• VertePort


SpinePlex

• AutoPlex

• PCD

•ACM

• VertePort


Features

• Immediatehighviscosityaftermixing

• Controlledinterdigitationandfill

• Workingtime–approximately18minutes

• Settimeof10.2minutesat37ºC

• Lowercreeprate

• Increasedviscosityimprovesvisibility

• 30% barium sulfate concentration

Proven performance.

SpinePlex is a derivative of Simplex P Bone Cement – the first surgical bone cement approved by the FDA, the first antibiotic-laden bone cement approved by the FDA8, and the most widely used bone cement in the world.9 SpinePlex contains thesamepolymethylmethacrylate(PMMA)andismanufactured using the same propriety process.

Features

• DerivativeofSimplexPBoneCement

• Workingtimeof10-12 minutes

• Settimeof8.2minutes at37ºC

• 30%bariumsulfate concentration

Extended working time.

Developed for physicians who want lower initial viscosity and longer working time. Advantageous for multiple level vertebroplasties and vertebral augmentations, VertaPlex maintains its toothpaste-like consistency for an average of 20 minutes.

Features

• Increasedworkingtime–approximately20minutes

• Settimeof10.2minutesat37ºC

• Lowcreeprate

• 30%bariumsulfate concentration

`

iVASTM: Inflatable Vertebral Augmentation System

Balloon Catheter

• Stiff distal balloon catheter provides rigidity for smooth insertion

• Flexible proximal catheter allows for easy maneuverability

• The radiopaque markers on the balloon catheter help facilitate accurate visualization and placement of the balloon

Access Cannula / Stylet

• The hand drill cuts cleanly through cancellous bone to create a channel for balloon placement

• Graduation markings on the access cannula assist in measuring needle depth

Specifications

Inflated Balloon Dimensions (as tested in water at 37°C)

Volume: 2mL 4mL 5mLLength(L): 16.7mm 24.0mm 27.0mmDiameter (D): 10.9 mm 14.9 mm 16.0 mm

Maximum Balloon Inflation ValuesVolume: 5mLPressure: 400 psi [27 atm]

iVAS

0705-115-000 (Sterile; 3 per box)10g iVAS System Kit (2-15 mm) Includes: balloon catheter, access cannula with diamond tip stylet, bevel tip stylet, locking syringe, inflator, stopcock

0705-115-500 (Sterile; 3 per box)10 gauge iVAS Balloon A la carte(2-15 mm)

Supplemental Products

0306-810-000 (Sterile; 6 per box)Hand Drill 10g

0306-410-000 (Sterile; 18 per box)VertePort Cement Cannulae 10g

0306-105-000 (Sterile; 6 per box)Bone Biopsy Kit 10g

Bipedicular Vertebral Augmentation

Unipedicular Vertebral Augmentation

D

L

The balloon is inflated, compacting the trabeculae and creating a cavity

Once the balloon is deflated and withdrawn, the cavity is filled with bone cement


Recommended Companion ProductsOrdering Information

• AutoPlex

• PCD

• VertePort

• VertaPlex HV

• VertaPlex

• SpinePlex

• Bone Biopsy Kit

Procedure Overview

The iVAS Inflatable Vertebral Augmentation System is your complete solution for treating VCFs with vertebral augmentation. During a vertebral augmentation, a balloon catheter is used to create a void

in a collapsed vertebra, helping to allow for controlled and contained cement delivery.2,11 Clinical results for vertebral augmentation show the potential for substantial pain relief,13 increased mobility, and improved quality of life.2,5,6,7,10,11,12

Simple. Certain. Defined. iVAS measures up to your expectations and your expertise.

`


0607-687-000 (Sterile; 2 per box)VertaPlex HV / AutoPlex System Kit without Needles Includes: One-half dose of VertaPlex HV bone cement, one AutoPlex mixer and delivery system

0605-687-000 (Sterile; 2 per box)AutoPlex System Kit without NeedlesIncludes: One-half dose of VertaPlex bone cement, one AutoPlex mixer and delivery system

0605-683-000 (Sterile; 2 per box)11g AutoPlex System KitIncludes: One-half dose of VertaPlex bone cement, one AutoPlex mixer and delivery system, one 11g 5" diamond tip match-ground introduction needle

0605-685-000 (Sterile; 2 per box)13g AutoPlex System KitIncludes: One-half dose of VertaPlex bone cement, one AutoPlex mixer and delivery system, one 13g 5" diamond tip match-ground introduction needle

0605-887-000 (Sterile; 2 per box)AutoPlex System Kit without Cement or NeedlesIncludes: One AutoPlex mixer and delivery system


• iVAS

• VertaPlexHV

• VertaPlex

• VertePort


AutoPlex® Mixer&DeliverySystem

AutoPlex is a fast and easy-to-use mixer and delivery system. Withthepressofasinglebutton,itmixes,transfers,andprimes(ready to inject) highly viscous bone cement for delivery in less than 60 seconds.

Mixing

• Automaticallymixes,transfers,primesandreadiescementfordelivery in less than 60 seconds, streamlining procedure time Unique to Stryker*

• Providesconsistentandthoroughmixing,eliminatinghumanerrorandvariability

Attach extension tube to delivery cartridge, pour powder and then liquid monomer through supplied funnel

Locklidontomixingchamber

Press and release mixing button

Detach tube from cement injector when mixing/transfer are complete

Remove cement injector from mixing unit

Procedure Overview

Delivery

• Lightweight,ergonomicdeliveryinjector

• Provides14ccofdeliverablecement

• Closedmixing,transfer,anddeliverysystemprevents exposure to harmful fumes

• Flexibleextensiontubeanddeliverycartridge–totaling 16" in length – helps ensure radiation safety Unique to Stryker*

• ErgonomicluerdesignUnique to Stryker*

• Delivers0.5ccperfullturn

• Simpleandreliablehandheldinjection


0505-582-000 (Sterile; 4 per box)10g PCD System KitIncludes: One-half dose of SpinePlex Bone Cement, one PCD mixer and delivery system, one 10g 5" diamond tip match-ground introduction needle, one 10g 5" interchangeable bevel stylet



0505-586-000 (Sterile; 4 per box)PCDSystemKitwith90ºShortExtensionTubeand without NeedlesIncludes: One-half dose of SpinePlex Bone Cement, one PCD mixer and delivery system with 90º short extension tube

0505-587-000 (Sterile; 4 per box)PCD System Kit without NeedlesIncludes: One-half dose of SpinePlex Bone Cement, one PCD mixer and delivery system

0505-589-000 (Sterile; 4 per box)PCD System Kit with Straight Short Extension Tube and without NeedlesIncludes: One-half dose of SpinePlex Bone Cement, one PCD mixer and delivery system with straight short extension tube

0507-589-000 (Sterile; 4 per box)VertaPlex HV / PCD System Kit with Straight Short Extension Tube and without NeedlesIncludes: One-half dose of VertaPlex HV Bone Cement, one PCD mixer and delivery system with straight short extension tube

0506-482-000 (Sterile; 4 per box)10g PCD System Kit without Cement Includes: One PCD mixer and delivery system, one 10g 5" diamond tip match-ground introduction needle, one 10g 5" interchangeable bevel stylet

0506-483-000 (Sterile; 4 per box) 11g PCD System Kit without CementIncludes: One PCD mixer and delivery system, one 11g 5" diamond tip match-ground introduction needle, one 11g 5" interchangeable bevel stylet 0506-485-000 (Sterile; 4 per box)13g PCD System Kit without CementIncludes: One PCD mixer and delivery system, one 13g 5" diamond tip match-ground introduction needle, one 13g 5" interchangeable bevel stylet 0506-486-000 (Sterile; 4 per box)PCD System Kit without Cement or NeedlesIncludes: One PCD mixer and delivery system

0506-489-000 (Sterile; 4 per box)PCD System Kit with Straight Short Extension Tube and without Cement or NeedlesIncludes: One PCD mixer and delivery system with straight short extension tube


• iVAS

• VertaPlex HV (short tube only)

• VertaPlex

• SpinePlex (one-half dose)

• VertePort


PCDTM: Precision Cement DeliveryAn all-in-one mixer and delivery system, PCD offers ease of use, desired cement consistency, and helps improve procedure efficiency.

Mixing

• Manuallymixesinapproximatelyoneminute

• Closedvacuummixingsystemisproventoenhancethecement’scapabilities

• Streamlinedtransferofmixedcementtodeliverycartridge

• Mixingbladeconsistentlyblendscementpowderandliquidtogethertoform desired viscosity

• “Lock-down”lidandcharcoalfilterlockinandevacuatePMMAfumes

Pour powder and monomer into funnel

Attach mixing blade and lock into place

Mixcementinanupand down motion while rotating the mixing handle

Remove hand mixer: push grey button inward, rotate clockwise, then pull handle straight up and out of mix chamber

Transfer and prime system by turning the base of the mixing chamber clockwise

Lockthedeliverycartridge with the extension tube attached onto the mixing chamber by rotating counter-clockwise

Procedure Overview

Delivery

•Hand-operated,allowingprecisedeliveryofmixedcement with 0.4 cc per full turn of delivery base

•Deliverycartridgeandextensiontubeprovideradiationsafety with more than 14" in total length

• Provides10ccofdeliverablecement

VertaPlex HV only compatible with short tube.

ACMisaprovenandcost-efficientsystemformixingcementundervacuum and transferring it into a cartridge, limiting exposure of staff to harmful fumes. The mixed cement is then loaded into syringes, affording physicians complete tactile feel and superior control.

Features

• Mixesinapproximately3-4minutes

• Closedvacuummixingsystemisproventoenhancethecement’scapabilities

• Decreasesporosityofthecement,makingitstrongerandlongerlasting

• “Lock-down”lidandcharcoalfilterlockinandevacuatePMMAfumes

• Easy-to-turnpaddlesscrapeandspreadcementforanidealandcomfortablemix

• Variousnozzlesandpressurizersareavailable

• Economicchoice


0405-583-000 (Sterile; 4 per box)11gACMSystemKitIncludes: One full dose of SpinePlex Bone Cement, one ACM system, one luer lock nozzle, two 11g 5" diamond tip match-ground introduction needles, two 5" bevel stylets, six 1cc syringes, two 3cc syringes

0405-584-000 (Sterile; 4 per box)ACMSystemKitwithoutNeedlesorSyringesIncludes: One full dose of SpinePlex Bone Cement, one ACM system, one luer lock nozzle

0405-585-000 (Sterile; 4 per box)13gACMSystemKitIncludes: One full dose of SpinePlex Bone Cement, one ACM system, one luer lock nozzle, two 13g 5" four-faceted match-ground introduction needles, two 5" bevel stylets, six 1cc syringes, two 3cc syringes

0405-586-000 (Sterile; 4 per box)ACMSystemKitwithoutNeedlesIncludes: One full dose of SpinePlex Bone Cement, one ACM system, one luer lock nozzle, six 1cc syringes, two 3cc syringes


• SpinePlex(fulldose)

• VertePort


NeedlesStryker’s needles help offer optimal control and maneuverability in accessing the vertebral body and delivering bone cement during VCF treatments. The easy-to-introduce match-ground diamond tips are sharp and efficient in cutting bone, while the beveled stylets are useful for changing the tip direction according to which way the bevel is oriented.14

Features

• Four-facetedoutercannulaisgrounddowntomatchstylet,reducingtissue ‘catching’ when introduced

• Diamond-andbevel-tippedstyletsareinterchangeablewithcannulae

• Bevelmarkingsindicatesteeringdirection

• Widerangeofneedlegaugesavailable,10-14gauge

• Radiolucenthandleshelpprovideclearvisibilityunderfluoroscopy

ACMTM: AdvancedCementMixing


0306-100-000 (Sterile; 6 per box)10g5"DiamondTipMatch-Ground Introduction Needle

0306-101-000 (Sterile; 6 per box)10g5"BevelTipMatch-Ground Introduction Needle



0306-114-000 (Sterile; 6 per box)11g4"DiamondTipMatch-Ground Introduction Needle and Bevel Stylet



0306-134-000 (Sterile; 6 per box)13g4"DiamondTipMatch-Ground Introduction Needle and Bevel Stylet



0306-150-000 (Sterile; 6 per box)11g 5" Bevel Tip Stylet without Needle

0306-160-000 (Sterile; 6 per box)13g 5" Bevel Tip Stylet without Needle


• AutoPlex

• PCD

• ACM

• VertePort

• VertaPlexHV

• VertaPlex

• SpinePlex(one-half dose and full dose)

• Bone Biopsy Kit


0306-400-000 (Sterile; 6 per box)10g5.75"LongStyletAccessCannula

0306-430-000 (Sterile; 6 per box)10g 5" Short Stylet Access Cannula

0306-110-000 (Sterile; 6 per box)11g 5" Short Stylet Access Cannula

0306-510-000 (Sterile; 18 per box)11g Cement Cannula (for use with 11g 5" access needle 0306-110-000)

0306-410-000 (Sterile; 18 per box)10g Cement Cannula (for use with 10g long and short access needles 0306-400-000 and 0306-430-000)


• iVAS

• AutoPlex

• PCD

• ACM

• VertaPlexHV

• VertaPlex

• SpinePlex

• BoneBiopsyKit

• 10gand11gNeedles

VertePort® Coaxial SystemVertePort is a coaxial, hollow-needle access system developed specifically for vertebral augmentation. The system offers multiple ways to deliver bone cement during VCF treatments.

By providing continuous access to the vertebral body, VertePort increases control while delivering cement with the use of a traditional injector.

If used to hand obturate cement delivery, VertePort’s mechanical advantage allows for delivery of thicker cement and increased working time compared to traditional injectors and syringes.

Filling of cement cannula using PCDCoaxial delivery of cement with VertePort Hand obturation

Approach Overview

Features

• Excellenttactilefeel

• 10and11gaugeoptions

• MaximizesflexibilityduringVCF treatment

• Providesconstantunobstructed access to the vertebral body

• Allowsforeasydeliveryof high-viscosity bone cement

• Precisecontrol

• Abilitytodelivercementthroughhand obturation and/or traditional injector

• Extendscementworkingtimewith use of hand obturation


0306-105-000 (Sterile; 6 per box) 10g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet

0306-195-000 (Sterile; 6 per box)10g 9" Bone Biopsy KitIncludes: Blunt tip, coaxial needle, inner stylet




• VertaPlexHV

• VertaPlex

• SpinePlex(one-half dose and full dose)

• AllMixersandDeliverySystems

• 10g5"DiamondTipMatch-Ground Introduction Needles




Vertebral Bone Biopsy KitThe Stryker Bone Biopsy Kit is compatible with our standard 10, 11, and 13 gauge 5" needles, as well as 10 gauge 9" needles. The coaxial design allows for biopsy collection of a core sample within the vertebral body. This streamlined technique can be used in conjunction with VCF procedures or independent biopsies.

Features

• Pre-packagedin10,11,and13gaugekits

• Easy,streamlinedapproach

• Enablesaccessforsubsequentprocedures

• Radiolucenthandlesallowunobstructedimageofbonylandmarks and precise needle placement













Bone Cements








0705-115-50010g iVAS Balloon Catheter (Sterile; 3 per box)(2-15 mm) A la carte 0306-810-000 10g Hand Drill (Sterile; 6 per box)













VertePort











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Bone Cements








0705-115-50010g iVAS Balloon Catheter (Sterile; 3 per box)(2-15 mm) Á la Carte 0306-810-000 10g Hand Drill (Sterile; 6 per box)













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StrykerIVS.com

Stryker Interventional Spine.

Your single source for VCF solutions.



StrykerIVS.com



Literature Number: 1000-025-036 Rev NoneDDM/PSCopyright © 2010 StrykerPrinted in USA

Stryker Instruments4100 East Milham AvenueKalamazoo, MI 49001 USAt: 269 323 7700 f: 800 999 3811toll free: 800 253 3210www.stryker.com

The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Products referenced with TM designation are trademarks of Stryker. Products referenced with ® designation are registered trademarks of Stryker.

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Footnotes1. National Osteoporosis Foundation. Disease facts. Available at: www.nof.org/ osteoporosis/diseasefacts.htm. Accessed

September 11, 20092. Siemionow, K and Lieberman, IH. Vertebral Augmentation in Osteoporotic and Osteolytic Fractures. Current Opinion in

Supportive and Palliative Care. 2009 Sept 3:219-2253. http://www.orthosupersite.com/view.asp?rID=1702 accessed Sept. 11, 20094. Lovi A, Teli M, Ortolina A, et al. Vertebroplasty and Kyphoplasty: Complementary Techniques for the Treatment of Painful

Osteoporotic Vertebral Compression Fractures. A Prospective Non-randomised Study on 154 Patients Eur Spine Jour (2009) 18 (Suppl 1):S95-S101

5. Passias PG, Li Gang, Wood, KB. SRS Position Paper: The Results of Vertebral Augmentation Procedures Department of Orthopaedic Spine Surgery Massachusetts General Hospital and Harvard Medical School Boston, MA Sept. 8, 2008

6. Lavelle W, Carl A, Lavelle ED, Khaleel MA. Vertebroplasty and Kyphoplasty, Anesthesiol Clin. 2007 Dec;25 (4):913-287. McKiernan F, Faciszewski T, Jensen R. Quality Of Life Following Vertebroplasty. J Bone Joint Surg Am. 2004

Dec;86-A(12):2600-6 8. The Worldwide Orthopaedic Market. Prepared by Knowledge Enterprises. October 2005, p. 119. Orthopaedic Industry Annual Report: 2008-2009. Orthoworld, Inc. 2009, p. 2210. Kochan, J. Vertebroplasty and Kyphoplasty, Percutaneous. http://emedicine.medscape.com/article/423209- overview

Accessed September 1, 2009. 11. Wardlaw, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P,Talmadge K, Boonen

S. Efficacy and Safety of Balloon Kyphoplasty Compared with Non-surgical Care for Vertebral Compression Fracture (FREE): a Randomized Controlled Trial www.thelancet.com Published online February 25, 2009 DOI:10.1016/S0140-6736(09)60010-6

12. Jensen ME, McGraw JK, Cardella JF, Hirsch JA. Position statement on percutaneous vertebral augmentation: A consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. J Vasc Interv Radiol 2009; 20:S326–S331

13. Eck JC, Nachtigall D, Humphreys SC, Hodges SD. Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature. The Spine Journal 2008; 8:488-497

14. Percutaneous Vertebroplasty and Kyphoplasty – Ed. 2 / Editors, John M Mathis, Hervé Deramond, Stephen M. Belkoff. Copyright 2006 by Springer Science+Business Media, Inc., p. 118

* Information current as of August 1, 2010

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