X-spine™ Surgical Technique

X-spine Systems SPIDER™Cervical Plating System

X-spine Systems SPIDER™ Cervical Plating System

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General DescriptionThe X-Spine Spider™ Cervical Plating System isintended for anterior screw fixation to the cervicalspine. The SCP system consists of a variety of shapesand sizes of bone plates and screws. The componentsare manufactured from titanium alloy (Ti 6Al 4V ELI)as described by ASTM F136. Components of the X-Spine SCP System should not be used withcomponents from any other system or manufacturer.The X-Spine SCP System components are providednon-sterile. The products need to be steam sterilizedby the hospital prior to use.

Indications for UseThe SCP system is indicated for use in thetemporary stabilization of the anterior spineduring the development of cervical spinal fusionin patients with degenerative disc disease (as defined by neck pain of discogenic originwith degeneration of the disc confirmed bypatient history and radiographic studies),spondylolisthesis, trauma (i.e., fractures ordislocations), tumors, deformity (defined askyphosis, lordosis, or scoliosis), pseudoarthrosis,and/or failed previous fusions.

Warnings1. This device is not approved for screw attachment

to the posterior elements (pedicles) of thecervical, thoracic, or lumbar spine.

2. Mixing of dissimilar metals can accelerate thecorrosion process. Stainless steel and titaniumimplants must NOT be used together in buildinga construct. The X-Spine SCP System should notbe used with components from any other systemor manufacturer. As with all orthopedic implants,the X-Spine SCP System should not be reusedafter use in an implant or prior to sterilization.

3. Always orient the Spider Cervical Plating asclose as possible to the spinal midline.

Due to the presence of implants, interference with roentgenographic, CT, and/or MR imagingwill result.

The X-Spine SCP System is only a temporaryimplant used for the correction and stabilization of the cervical spine. The system is also used toaugment the development of a spinal fusion byproviding temporary stabilization. This devicesystem is not intended to be the sole means ofspinal support. Bone grafting must be part of thespinal fusion procedure in which the X-Spine SCPSystem is utilized. Use of this product without abone graft or in cases that develop into a nonunionwill not be successful. The spinal implant cannotwithstand body loads without the support of bone.In this event, bending, loosening, disassembly andor breakage of the device will eventually occur.

Please refer to the Package Insert for acomprehensive listing of warnings and precautions.

PrecautionsThe X-Spine SCP System should only be implantedby surgeons who are fully experienced in the useof such implants and the required specializedspinal surgery techniques. Further, the properselection and compliance of the patient will greatlyaffect the results. The surgeon should consider thepatient conditions (e.g., smoker, malnutrition,obesity, alcohol and drug abuse, poor muscle and bone quality), which may impact systemperformance.

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X-spine Systems SPIDER™ Cervical Plating System

X-spine™ Surgical Technique

This publication recommends procedures for using X-spine products and instruments. The guidance it offers is for surgeon consideration, but, as with any technicalguide, the surgeon must evaluate the specific requirements of the patient, making appropriate adjustments as needed.

1. Site PreparationThe anterior cervical spine is exposed via thestandard surgical approach of Cloward. Interbodybone grafting is performed at the desired disklevels. The ventral cortical surface must be free ofosteophytes and smooth in profile prior to plateplacement.

2. SizingA plate is selected such that the screw sockets arelocated in the mid-portion of the vertebra. The plateshould be centered in the midline and confirmed usinganatomical landmarks and AP radiography.

Sizing may be determined by using the Neuro Caliperinstrument. Plate sizing corresponds to the overall platelength, not screw socket distance. A Plate HoldingInstrument is provided to assist in plate placement.

4. Fixation Pin PlacementFixation Pins may be placed in the screw socketsas needed. The Fixation pins may be insertedand extracted with the Fixation Pin Inserter.

CAUTION - The Fixation Pins should be orientedso that the flats are medial and lateral.

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3. Plate BendingThe SPIDER plate comes with a standard lordoticcurve. If additional lordosis is required, the PlateBending Instrument may be used. The plate should bebent within the Bending Zone. To increase the lordoticcurve further, bend the plate at multiple locationsacross the Bending Zone.

CAUTION - Once bent, avoid reverse bending theplate in the same location. This may result in plateweakening and premature fatigue fracture.

CAUTION - Avoid bending the plate in the region ofthe locking mechanism. This may result in screwlocking mechanism malfunction.

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6. DrillingThe SPIDER Cervical Plating System is designedto be used with the self-drilling screws provided.Self-drilling screws preserve cancellous bone forscrew purchase and generally result in improvedscrew fixation compared with drilled screws. In cases where there is unusually hard bonepresent, drilling can be performed. If drilling isdesired, the drill guide instruments are used toguide the drill bit through each screw socket.

Drill bits are provided in 12, 14, and 16mmlengths, corresponding to the available screwlengths. The drill bits have a standard AO quick-connect coupling. A ratcheting handle for hand-drilling is provided.

CAUTION - Excessive angulation force on anydrill guide should be avoided. Over-angulationof the drilled hole beyond 7.5 degrees mayresult in failure of the screw to engage the plate and/or locking mechanism.

5. Bone AwlThe bone awl instrument is used to penetratethe cortical bone via each screw socket.Optionally, fixation pins may be placedthrough the screw sockets to temporarily hold the plate in the midline.

OPTION 3: Double Barrel All-In-One Drill Guide

The Double Barrel All-In-One Drill Guideinstrument may be used as an alternative to the Variable Single Barrel Drill Guideinstrument. The Double Barrel All-In-OneDrill Guide instrument has a tip which isdimensioned to be engaged into the slotted area adjacent to the screw sockets.The Double Barrel All-In-One Drill Guideinstrument allows for the placement of the Bone awl, Thread Tap, and Hex Driverthrough the guide while it is engaged in the plate. Each barrel contains a removableDrill Insert which must be removed to allowthe use of the instruments through the guide.

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OPTION 2: Fixed Single Barrel Drill Guide

The Fixed Single Barrel Drill guide has a hard-stopmechanism to prevent significant angulation of theguide with respect to the plate. The drill guide tiphas flats on the lateral sides (with the handle inthe rostral or caudal position). The flats allow forthe drill guide to engage the screw socket withoutimpacting the locking arm, which should beavoided. The Fixed Single Barrel Drill guide is intended to be used with fixed (magenta or green) screws.

OPTION 1: Variable Single Barrel Drill Guide

The Variable Single Barrel Drill guide allows for approximately 15 degrees of total drillangulation with respect to the plate. It has a soft-stop mechanism to indicate over-angulation.It is important not to force the guide past 7.5degrees in any direction. The drill guide tip hasflats on the lateral sides (with the handle in therostral or caudal position). The flats allow for the drill guide to engage the screw socketwithout impacting the locking arm, which should be avoided. The Variable Single BarrelDrill Guide is intended to be used with variable(blue or yellow) screws.

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9. Screw AngulationCAUTION- Angulating the variable screwsgreater than 7.5 degrees in any one directionmay prevent the screw from engaging the plateand/or locking mechanism properly.

8. Screw SelectionScrews are available in 12, 14 and 16mmlengths and the following Diameters:

4.00mm Variable Blue4.25mm Variable Yellow4.00mm Fixed Magenta4.25mm Fixed Green

7. Thread TappingThe provided screws are fluted for selftapping. For unusually hard bone, a 4 mm threaded tap is provided.

11. Screw RemovalIf a screw needs to be removed, the screw removaltool is placed into the slotted area adjacent to thescrew socket. The Screw Removal Instrument shouldfully engage the plate and by doing so will retractboth locking arms of a screw socket pair. The ScrewRemoval Instrument has a built in 15 degreeangulation with respect to the plate. This allows forclearance of the hex-driver. The Hex Driver can thenbe used to withdraw the screw.

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10. Screw PlacementThe Hex Driver instrument is used to drive the screwsinto bone. The Hex Driver tip is designed to self-retain the screw. As the screw is tightened intobone, the screw head will pass through the resilientlocking arm. An audible and tactile click should benoted as the screw engages the locking mechanism.Positioning of the locking tab in front of the screwshoulder should be visually confirmed.

CAUTION - Placement of high torque force duringscrew tightening may result in plate damage,stripping of bone and weakening of the bone/screwinterface. If screw stripping or other compromise ofthe bone/screw interface occurs, placement of awider and/or longer screw is advised, withinanatomical limitations. If screw replacement fails toestablish adequate strength, repositioning of theplate is advised. Following plate placement,radiography is recommended to confirmappropriate positioning.

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SPIDER® Plating System Instruments

Spider Screw Removal Device – #N60000190

Spider Plate Holder – #N60000089

Spider Tap – #N60000170

Spider Awl – #N60000165

Spider Fixation Pin Impactor – #N60001054

Spider Drill – #N60000175,176,177

Spider Double Barrel Drill Guide – #X009-0001

Spider Single Barrel Drill Guide – #N60000180 & #N60001050

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Plate Bender – #N60000192

Neuro-Caliper – #N60000482

X-spine Systems, Inc.452 Alexandersville Rd., Miamisburg, OH 45342

Phone: 800-903-0640 • Direct: 937-847-8400 • Fax: 937-847-8410www.x-spine.com

F-1000.8 Rev A. 12/11 I2M/CIEC60-1065

WARNING: In the USA, this product has labeling limitations.See package insert for complete information.

CAUTION: Federal Law (USA) restricts this device to sale by oron the order of a physician.

X-spine™ the X-spine logo and SPIDER® are trademarks of X-spine Systems, Inc.

Products Patented and Patents Pending

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© 2008 X-spine Systems, Inc., All rights reserved.