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Proximal Lateral Tibia

Operative Technique

AxSOSLocking Plate System

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ContentsPage

1. Introduction 4

2. Features & Benefits 5

3. Relative Indications & Contraindications 6

4. General Guidelines 7

Patient Positioning 7

Surgical Approach 7

Reduction 7

Bending 7

Locking Screw Measurement 8

Correct Screw Selection 8

Measurement Options 8

Soft-Tissue Reattachment 8

5. Operative Steps 9

Pre-Operative Planning 9

Pre-Operative Locking Insert Application 9

Locking Insert Extraction 9

Intra-Operative Locking Insert Application 10

Aiming Block/Plate Insertion Handle Assembly 10

Plate Application 11

Primary Plate Fixation - Proximal 11

Primary Plate Fixation - Distal 12

Metaphyseal Locking 12

Shaft Fixation 13

Standard Screws 13

Locking Screws 14

Kick-Stand Screw Placement 14

Sub-Muscular Insertion Technique 15

Additional Tips 16

Ordering Information – Implants 17

Ordering Information – Screws 18

Ordering Information – 4.0mm Instruments 19

Additional Information – Hydroset Injectable HA 21

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Introduction

The AxSOS Locking Plate Systemis designed to treat periarticularor intra-articular fractures of theProximal and Distal Tibia, ProximalHumerus and Distal Femur.The system design is based on clinicalinput from an international panel ofexperienced surgeons, data fromliterature, and both practical andbiomechanical testing.

The anatomical shape, the fixed screwtrajectory, and high surface quality takeinto account the current demands ofclinical physicians for appropriatefixation, high fatigue strength,and minimal soft tissue damage.

This Operative Technique contains asimple step-by-step procedure for theimplantation of the Proximal LateralTibial Plate.

Distal MedialTibial Plate

Distal AnterolateralTibial Plate

Proximal HumeralPlate

Proximal LateralTibial Plate

Distal LateralFemoral Plate

This publication sets forth detailed recommendedprocedures for using Stryker Osteosynthesis devices andinstruments.

It offers guidance that you should heed, but, as with anysuch technical guide, each surgeon must consider theparticular needs of each patient and make appropriateadjustments when and as required.

A workshop training is recommended prior to firstsurgery.

Features & Benefits

System

• The Proximal Lateral Tibial Plate isdesigned with divergent fixed-angledscrew trajectories which provideimproved biomechanical stability andbetter resistance to pull out. Thishelps prevent loss of reduction.

Instruments

• Simple technique, easyinstrumentation with minimalcomponents.

• Compatible with MIPO(Minimally Invasive PlateOsteosynthesis) technique usingstate of the art instrumentation.

Range

• Longer plates cover a wider rangeof fractures.

Unthreaded Freedom Holes

• Freehand placement of screws.

• Lag Screw possibility.

Kick-Stand Screw

• Aimed at posterior/medial fragmentto provide strong triangular fixation.

‘Waisted’ plate shape

• Uniform load transfer.

Rounded & Tapered Plate End

• Helps facilitate sliding of platessub-muscularly.

K-Wire/Reduction/Suture holes

• Primary/temporary plate andfracture fixation.

• Anchor point for soft tissuere-attachment.

Anatomically contoured

• Little or no bending required.

• Reduced OR time.

Shaft Holes - Standard or Locking

• Bi-directional shaft holes.

• Compression, neutral orbuttress fixation.

• Accept Standard 3.5/4.0mmSPS screws.

• Accept Locking Insert for axiallystable screws.

Innovative Locking Screw design

• The single thread screw designallows easy insertion into the plate,reducing any potential for crossthreading or cold welding.

Monoaxial holes (5)

• Allow axially stable screw placement,bringing rigidity to construct.

Aiming Block

• Facilitates the placement of theDrill Sleeve.

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Relative Indications & Contraindications

The indication for use of this internalfixation device includes metaphysealextra and intra articular fractures ofthe proximal Tibia.

The physician's education, training andprofessional judgement must be reliedupon to choose the most appropriatedevice and treatment. The followingcontraindications may be of a relativeor absolute nature, and must be takeninto account by the attending surgeon:

• Any active or suspected latentinfection or marked localinflammation in or about theaffected area.

• Compromised vascularity that wouldinhibit adequate blood supply to thefracture or the operative site.

• Bone stock compromised by disease,infection or prior implantation thatcan not provide adequate supportand/or fixation of the devices.

• Material sensitivity, documentedor suspected.

• Obesity. An overweight or obesepatient can produce loads on theimplant that can lead to failure ofthe fixation of the device or tofailure of the device itself.

• Patients having inadequate tissuecoverage over the operative site.

• Implant utilisation that wouldinterfere with anatomical structuresor physiological performance.

• Any mental or neuromusculardisorder which would create anunacceptable risk of fixation failure orcomplications in postoperative care.

• Other medical or surgical conditionswhich would preclude the potentialbenefit of surgery.

Detailed information is included inthe instructions for use being attachedto every implant.

See package insert for a completelist of potential adverse effects andcontraindications. The surgeon mustdiscuss all relevant risks, including thefinite lifetime of the device, with thepatient, when necessary.

Caution:Bone Screws are not intended forscrew attachment or fixation tothe posterior elements (pedicles)of the cervical, thoracic or lumbarspine.

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Relative Indications

Relative Contraindications

Operative Technique

General Guidelines

Reduction

Anatomical reduction of the fractureshould be performed either bydirect visualisation with the help ofpercutaneous clamps, or alternativelya bridging external Fixator can aid withindirect reduction. Fracture reductionof the articular surface should beconfirmed by direct vision, orfluoroscopy. Use K-Wires as necessaryto temporarily secure the reduction.

Typically, K-Wires set parallel to thejoint axis will not only act to hold andsupport the reduction, but also help tovisualise/identify the joint.

Care must be taken that these do notinterfere with the required plate andscrew positions. Consideration mustalso be taken when positioningindependent Lag Screws prior to plateplacement to ensure that they do notinterfere with the planned platelocation or Locking Screw trajectories.

If any large bony defects are presentthey should be filled by either bonegraft or bone substitute material.

Note:If a sub-muscular technique hasbeen used please see the relevantsection later in this Guide.

Bending

In most cases the pre-contoured platewill fit without the need for furtherbending. However, should additionalbending of the plate be required(generally at the junction from themetaphysis to the shaft) the BendingIrons (REF 702756) should be used.Bending of the plate in the region ofthe metaphyseal locking holes willaffect the ability to correctly seat theLocking Screws into the plate and istherefore not permitted.Plate contouring in the shaft regionshould be restricted to the areabetween the shaft holes. Platecontouring will affect the ability toplace a Locking Insert into the shaftholes adjacent to the bending point.

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Patient Positioning: Supine with option to flex the knee.Visualisation of the proximal tibiaunder Fluoroscopy in both the lateraland AP views is necessary.

Surgical Approach: Lateral Parapatellar.Lateral curved (hockey stick) or straight.

Conventional direct

Measure off K-Wire

Measure off Drill

Operative Technique

General Guidelines

Locking Screw Measurement

There are four options to obtain theproper Locking Screw length asillustrated below.

Measurement Options

Soft-Tissue Reattachment

Special undercuts on the reverseside of the plate correlating to the twoproximal K-Wire holes allows simplepassing of sutures for meniscusreattachment after final plate fixation.

Read off Calibration

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Correct Screw Selection

Select a screw approximately 2-3mmshorter than the measured length toavoid screw penetrations through theopposite cortex in metaphysealfixation.

Add 2-3mm to measured length foroptimal bi-cortical shaft fixation.

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Fig. 2

Step 1 – Pre-Operative Planning

Use of the X-Ray Template (REF981091) or Plate Trial (REF 702793) inassociation with fluoroscopy can assistin the selection of an appropriatelysized implant (Fig. 1 & Fig. 1A).

If the Plate Trial is more than 90mmaway from the bone, e.g. with obesepatients, a magnification factor of10-15% will occur and must becompensated for. Final intraoperativeverification should be made to ensurecorrect implant selection.

Fig. 2A

Fig. 1

Operative Technique

Step 2a – Pre-OperativeLocking Insert Application

If Locking Screws are chosen for theplate shaft, pre-operative insertionof Locking Inserts is recommended.

A 4.0mm Locking Insert (REF 370002)is attached to the Locking Insert Inserter(REF 702762) and placed into thechosen holes in the shaft portion of theplate (Fig. 2). Ensure that the LockingInsert is properly placed. The Insertershould then be removed (Fig. 2A).

Note:Do not place Locking Inserts withthe threaded Drill Sleeve.

It is important to note that if aTemporary Plate Holder is to be usedfor primary distal plate fixation, then aLocking Insert must not be placed inthe same hole as the Temporary PlateHolder (See Step 6).

Locking Insert Extraction

Should removal of a Locking Insertbe required for any reason, then thefollowing procedure should be used.Thread the central portion (A) of theLocking Insert Extractor (REF 702767)into the Locking Insert that you wishto remove until it is fully seated (Fig 2B).Then turn the outer sleeve/collet (B)clockwise until it pulls the LockingInsert out of the plate (Fig. 2C). TheLocking Insert must then be discarded,as it cannot be reused.

B

A

Fig. 2B

Fig. 2C

Fig. 1A

Operative Steps

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Operative Technique

Fig. 4

Step 3 – Aiming Block/Plate Insertion Handle Assembly

Screw the appropriate Aiming Block(REF 702728/702729) to the plateusing the Screwdriver T15(REF 702747). If desired, the Handlefor Plate Insertion (REF 702778) cannow be attached to help facilitate platepositioning and sliding of longer platessub-muscularly (Fig. 4).

Step 2b – Intra – OperativeLocking Insert Application

If desired, a Locking Insert can beapplied in a standard hole(s) in the shaftof the plate intra-operatively by using theLocking Insert Forceps (REF 702968),Centering Pin (REF 702673), Adaptor forCentering Pin (REF 702675), and Guidefor Centering Pin (REF 702671).

First, the Centering Pin is insertedthrough the chosen hole using theAdaptor and Guide (Fig. 3A). It isimportant to use the Guide as thiscenters the core hole for Locking Screwinsertion after the Locking Insert isapplied. After inserting the CenteringPin bi-cortically, remove the Adaptor andGuide.

Next, place a Locking Insert on the endof the Forceps and slide the instrumentover the Centering Pin down to the hole(Fig. 3B).

Last, apply the Locking Insert bytriggering the forceps handle.Push the button on the Forcepsto remove the device (Fig. 3C). At thistime, remove the Centering Pin.

Fig. 3A

Fig. 3B Fig. 3C

Step 4 – Plate Application

After skin incision is performed andanatomical reduction is achieved,apply the plate so that the lateral tibialplateau is supported, with the proximalend of the plate approximately 5mmbelow the articular surface (Fig. 5).

This helps to ensure that the mostproximal Locking Screws are directlysupporting the joint surface.

Step 5 – Primary Plate Fixation –Proximal

The K-Wire hole just distal to theoblong hole allows temporary platefixation in the metaphysis (Fig. 6).

Remove the Handle for Insertion bypressing the metal button at the endof the Handle.

Using the K-Wire Sleeve (REF 702702)in conjunction with the Drill Sleeve(REF 702707), a 2.0x230mm K-Wirecan now be inserted into the mostposterior Locking Screw hole (Fig. 7).

This step shows the position of aposterior screw and also shows itsrelation to the joint surface. It will alsoconfirm the screw will not be placedintra-articularly or too posterior exitingthe cortex into the pupliteal space.

Using fluoroscopy, the position ofthis K-Wire can be checked untilthe optimal position is achievedand the plate is correctly positioned.Correct distal placement should also bere-confirmed at this point to make surethe plate shaft is properly aligned overthe lateral surface of the Tibial shaft(Fig. 6). If the proximal and axialalignment of the plate cannotbe achieved, the K-Wires should beremoved, the plate readjusted, and theabove procedure repeated until boththe posterior K-Wire and the plate arein the desired position.

Additional K-Wires can be insertedin the K-Wire holes superior to thelocking holes to further help securethe plate to the bone and also supportdepressed areas in the articular surface.

Do not remove the Drill Sleeve andK-Wire Sleeve at this point as it willcause a loss of the plate position.

Using a 2.5mm Drill (REF 700355 -230mm or 700347-125mm) andDouble Drill Guide (REF 702418),drill a core hole to the appropriatedepth in the oblong hole of the plate.

The length is then measured usingthe Depth Gauge for Standard Screws(REF 702879) and an appropriateself-tapping 3.5mm Cortical Screwor a 4.0mm Cancellous Screw isthen inserted using Screwdriver(REF702841) (Fig. 8). If insertinga cancellous screw, the near cortexmust be pre-tapped using the Tap(REF 702805), and the TeardropHandle (REF 702428).

The K-Wire below the oblong hole cannow be removed.

Operative Technique

Fig. 5 – Lateral ViewFig. 5 – AP View

Fig. 6

Fig. 7

Fig. 8

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Step 6 – Primary Plate Fixation –Distal

The distal end of the plate must nowbe secured. This can be achievedthrough one of four methods:

• A K-Wire inserted in the distal shaftK-Wire hole.

• A 3.5mm Cortical Screw using thestandard technique.

• A 4.0mm Locking Screw with aLocking Insert (see Step 8 – ShaftLocking).

• The Temporary Plate Holder(REF 702776).

In addition to providing temporaryfixation, this device pushes the plateto the bone. Also, it has a self drilling,self tapping tip for quick insertioninto cortical bone.

To help prevent thermal necrosisduring the drilling stage, it isrecommended that this deviceis inserted by hand.

Once the device has been insertedthrough the far cortex, the threadedouter sleeve/collet is turned clockwiseuntil the plate is in contact with thebone (Fig. 9). The core diameter ofthis instrument is 2.4mm to allow a3.5mm Cortical Screw to besubsequently inserted in the same shafthole.

Note:A Locking Insert and LockingScrew should not be used in thehole where the Temporary PlateHolder is used.

Operative Technique

Fig. 9

Fig. 10

Fig. 12Fig. 11

The Drill Sleeve should now be removed,and the correct length 4.0mm LockingScrew is inserted using the ScrewdriverT15 (REF 702747) and Screw HoldingSleeve (REF 702732) (Fig. 12).

Locking Screws should initially beinserted manually to ensure properalignment.

Note:It the Locking Screw thread doesnot immediately engage the platethread, reverse the screw a fewturns and re-insert the screw onceit is properly aligned.

Step 7 – Metaphyseal Locking

Locking Screws cannot act asLag Screws. Should aninterfragmentary compression effect berequired, a 4.0mm StandardCancellous Screw or a 3.5mm CortexScrew must first be placed in theunthreaded metaphyseal plate holes(Fig. 10) prior to the placement of anyLocking Screws. Measure the length ofthe screw using the Depth Gauge forStandard Screws (REF 702879), andpre-tap the near cortex with the Tap(REF 702805) if a cancellous screw isused. Consideration must also be takenwhen positioning this screw to ensurethat it does not interfere with the givenLocking Screw trajectories.

Fixation of the metaphyseal portionof the plate can be started using thepreset K-Wire in the posterior lockinghole as described in Step 5.The length of the screw can be takenby using the K-Wire side of the Drill/K-Wire Depth Gauge (REF 702712)(See Locking Screw MeasurementGuidelines on Page 8).

Remove the K-Wire and K-Wire Sleeveleaving the Drill Sleeve in place.

A 3.1mm Drill (REF 702742) is thenused to drill the core hole for theLocking Screw (Fig. 11).Using Fluoroscopy, check the correctdepth of the drill, and measure thelength of the screw.

Operative Technique

Step 8 – Shaft Fixation

The shaft holes of this plate havebeen designed to accept either 3.5mmStandard Cortical Screws or 4.0mmLocking Screws together with thecorresponding Locking Inserts.

If a combination of Standard andLocking Screws is used in the shaft,then the Standard Cortical Screwsmust be placed prior to theLocking Screws.

Option 1 – Standard Screws

3.5mm Standard Cortical Screws canbe placed in neutral, compression orbuttress positions as desired using therelevant Drill Guide and the standardtechnique.

These screws can also act as lag screws.

Figure 11

Fig. 13

Final tightening of Locking Screwsshould always be performed manuallyusing the Torque LimitingAttachment (REF 702750) togetherwith the Solid Screwdriver T15 (REF702753) and T-Handle (REF 702427)(Fig. 13).This helps to prevent over-tighteningof Locking Screws, and also ensuresthat these Screws are tightened to atorque of 4.0Nm. The device willclick when the torque reaches 4Nm.

Note:The Torque Limiters requireroutine maintainance. Refer to theInstructions for Maintainance ofTorque Limiters (REF V15020).

If inserting Locking Screws underpower, make sure to use a low speedto avoid damage to the screw/plateinterface, and perform final tighteningby hand, as described above.

The remaining proximal LockingScrews are inserted following the sametechnique with or without the use ofa K-Wire.

14º TransverseAngulation

70º Axial AngulationLocked Hole

Buttress

Compression

Neutral Drill SleeveHandle

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Note:Ensure that the screwdriver tip isfully seated in the screw head, butdo not apply axial force duringfinal tightening.

Always use the Drill Sleeve(REF 702707)when drilling for lockingholes. To ensure maximum stability,it is recommended that all lockingholes are filled with a Locking Screwof the appropriate length.

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Operative Technique

Step 9 – Kick-Stand ScrewPlacement

The oblique ‘Kick-Stand’ LockingScrew (Fig. 15) provides strongtriangular fixation to the proximalfragments. It is advised that this screwis placed with the assistance offluoroscopy to prevent joint penetrationand impingement with the proximalScrews (See Step 7 for insertionguidelines). The Aiming Blockshould now be removed.

Fig. 15

Option 2 – Locking Screws

4.0mm Locking Screws can be placedin the shaft holes provided there is apre-placed Locking Insert in the hole.(See Step 2).

The Drill Sleeve(REF 702707) isthreaded into the Locking Insert toensure initial fixation of the LockingInsert into the plate. This will alsofacilitate subsequent screw placement.A 3.1mm Drill Bit (REF 702742)is used to drill through both cortices.(Fig. 14).

Avoid any angulation or excessive forceon the drill, as this could dislodge theLocking Insert. The screwmeasurement is then taken.

The appropriate sized Locking Screwis then inserted using the SolidScrewdriver T15 (REF 702753)and the Screw Holding Sleeve(REF 702732) together with the TorqueLimiting Attachment (REF 702750)and the T-Handle (REF 702427).

Note:Ensure that the screwdriver tip isfully seated in the screw head, butdo not apply axial force duringfinal tightening.

Maximum stability of the LockingInsert is achieved once the screw headis fully seated and tightened to 4.0Nm.

This procedure is repeated for all holeschosen for locked shaft fixation.

All provisional plate fixation devices(K-Wires, Temporary Plate Holder, etc.)can now be removed.

Fig. 14

Fig. 16 Fig. 17 Fig. 18

Final plate and screw positions areshown in Figures 16–18.

Operative Technique

Fig. 19

Sub-Muscular InsertionTechnique

When implanting longer plates,a minimally invasive technique canbe used.

The Soft Tissue Elevator (REF 702782)can be used to create a pathway for theimplant (Fig. 19).The plate has a special rounded andtapered end, which allows a smoothinsertion under the soft tissue(Fig. 20).

Additionally, the Shaft Hole Locatorcan be used to help locate the shaftholes. Attach the appropriate side ofthe Shaft Hole Locator (REF 702793)by sliding it over the top of the Handleuntil it seats in one of the grooves at anappropriate distance above the skin.

The slot and markings on the ShaftHole Locator act as a guide to therespective holes in the plate. A smallstab incision can then be madethrough the slot to locate the holeselected for screw placement (Fig. 21).The Shaft Hole Locator can then berotated out of the way or removed.

Fig. 20

Fig. 21

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The Standard Percutaneous DrillSleeve (REF 702709) or NeutralPercutaneous Drill Sleeve (REF 702957)in conjunction with the Drill SleeveHandle (REF 702822) can be used toassist with drilling for Standard Screws.Use a 2.5mm Drill Bit (REF 700355).

With the aid of the Soft Tissue Spreader(REF 702919), the skin can be openedto form a small window (Fig. 22)through which either a Standard Screwor Locking Screw (provided a LockingInsert is present) can be placed.

For Locking Screw insertion, use thethreaded Drill Sleeve (REF 702707)together with the 3.1mm Drill Bit(REF 702742) to drill the core hole.

Fig. 22

Figure 14

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Additional Tips

1. Always use the threaded Drill Sleevewhen drilling for Locking Screws(threaded plate hole or LockingInsert).

Free hand drilling will lead to amisalignment of the Screw andtherefore result in screw jammingduring insertion. It is essential, to drillthe core hole in the correct trajectoryto facilitate accurate insertion of theLocking Screws.

If the Locking Screw thread does notimmediately engage the plate thread,reverse the screw a few turns andre-insert the screw once it is properlyaligned.

2. Always start inserting the screwmanually to ensure properalignment in the plate thread andthe core hole.It is recommended to start insertingthe screw using “the three fingertechnique” on the Teardrop handle.Avoid any angulations or excessiveforce on the screwdriver, as thiscould cross-thread the screw.

Power can negatively affect Screwinsertion, if used improperly,damaging the screw/plate interface(screw jamming). This can lead toscrew heads breaking or being stripped.

Again, if the Locking Screw does notadvance, reverse the screw a few turns,and realign it before you startre-insertion.

3. If power insertion is selected aftermanual start (see above), use lowspeed only, do not apply axialpressure, and never “push” thescrew through the plate!

Allow the single, continuousthreaded screw design to engage theplate and cut the thread in the boneon its own, as designed.

Stop power insertion approximately1cm before engaging the screw headin the plate.

4. It is advisable to tap hard (dense)cortical bone before inserting aLocking Screw.

5. Do not use power for finalinsertion of Locking Screws It isimperative to engage the screw headinto the plate using the TorqueLimiting Attachment. Ensure thatthe screwdriver tip is fully seated inthe screw head, but do not applyaxial force during final tightening.

If the screw stops short of finalposition, back up a few turns andadvance the screw again (withtorque limiter on).

The spherical tip of the Tap preciselyaligns the instrument in the predrilledcore hole during thread cutting.This will facilitate subsequent screwplacement.

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Ordering Information - Implants

Stainless Steel Plate Shaft LockingREF Length Holes Holes

Left Right mm

438302 438322 95 2 5438304 438324 121 4 5438306 438326 147 6 5438308 438328 173 8 5438310 438330 199 10 5438312 438332 225 12 5438314 438334 251 14 5

Stainless Steel SystemREF mm

370002 4.0

PROXIMAL LATERAL TIBIALocking Screws Ø4.0mmStandard Screws Ø3.5, 4.0mm

4.0MM LOCKING INSERT

Note: For Sterile Plates add ‘S’ to REF (Available as special order only)

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Stainless Steel ScrewREF Length mm

371514 14371516 16371518 18371520 20371522 22371524 24371526 26371528 28371530 30371532 32371534 34371536 36371538 38371540 40371542 42371544 44371546 46371548 48371550 50371555 55371560 60371565 65371570 70371575 75371580 80371585 85371590 90371595 95

Stainless Steel ScrewREF Length mm

345514 14345516 16345518 18345520 20345522 22345524 24345526 26345528 28345530 30345532 32345534 34345536 36345538 38345540 40345545 45345550 50345555 55345560 60345565 65345570 70345575 75345580 80345585 85345590 90345595 95

Stainless Steel ScrewREF Length mm

338614 14338616 16338618 18338620 20338622 22338624 24338626 26338628 28338630 30338632 32338634 34338636 36338638 38338640 40338642 42338644 44338646 46338648 48338650 50338655 55338660 60338665 65338670 70338675 75338680 80338685 85338690 90338695 95

Stainless Steel ScrewREF Length mm

345414 14345416 16345418 18345420 20345422 22345424 24345426 26345428 28345430 30345432 32345434 34345436 36345438 38345440 40345445 45345450 50345455 55345460 60345465 65345470 70345475 75345480 80345485 85345490 90345495 95

4.0MM LOCKING SCREW, SELF TAPPINGT15 DRIVE

3.5MM CORTICAL SCREW, SELF TAPPING2.5MM HEX DRIVE

Ordering Information - Screws

4.0MM CANCELLOUS SCREW, PARTIAL THREAD2.5MM HEX DRIVE

4.0MM CANCELLOUS SCREW, FULL THREAD2.5MM HEX DRIVE

Note: For Sterile Implants add ‘S’ to REF

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REF Description

4.0mm Locking Instruments

702742 Drill Ø3.1mm x 204mm

702772 Tap Ø4.0mm x 140mm

702747 Screwdriver T15, L200mm

702753 Solid Screwdriver T15, L115mm

702732 Screw Holding Sleeve

702702 K-Wire Sleeve

702707 Drill Sleeve

702884 Direct Depth Gauge for Locking Screws

702750 Torque Limiter T15/4.0mm

702762 Locking Insert Inserter 4.0mm

702427 T-Handle small, AO Fitting

38111090 K-Wire Ø2.0mm x 230mm

702767 Locking Insert Extractor

702778 Handle for Plate Insertion

702712 Drill/K-Wire Measure Gauge

702776 Temporary Plate Holder

702776-1 Spare Shaft for Temporary Plate Holder

702919 Soft Tissue Spreader

702961 Trocar (for Soft Tissue Spreader)

702782 Soft Tissue Elevator

702756 Bending Irons (x2)

Ordering Information - 4.0mm Instruments

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Ordering Information - 4.0mm Instruments

REF Description

4.0mm Locking Instruments

702729 Aiming Block, Proximal Tibia, Left

702728 Aiming Block, Proximal Tibia, Right

702720-2 Spare Set Screw for Tibia Aiming Block

702793 Plate Trial/Shaft Hole Locator - Proximal Tibia

SPS Standard Instruments

700347 Drill Bit Ø2.5mm x 125mm, AO700355 Drill Bit Ø2.5mm x 230mm, AO700353 Drill Bit Ø3.5mm x 180mm, AO702804 Tap Ø3.5mm x 180mm, AO702805 Tap Ø4.0mm x 180mm, AO702418 Double Drill Guide Ø2.5/3.5mm702822 Drill Sleeve Handle702825 Drill Sleeve Ø2.5mm Neutral702829 Drill Sleeve Ø2.5mm Compression702831 Drill Sleeve Ø2.5mm Buttress702709 Percutaneous Drill Sleeve Ø2.5mm702957 Percutaneous Drill Sleeve Ø2.5mm Neutral702879 Depth Gauge 0-150mm for Screws Ø3.5/4.0mm702841 Screwdriver Hex 2.5mm for Standard Screws L200mm702485 Solid Screwdriver Hex 2.5mm for Standard Screws L115mm702490 Screwdriver Holding Sleeve for Screws Ø3.5/4.0mm702428 Tear Drop Handle, small, AO Fitting900106 Screw Forceps390192 K-Wires 2.0mm x 150mm

Other Instruments

702968 Locking Insert Forceps

702671 Guide for Centering Pin

702673 Centering Pin

702675 Adapter for Centering Pin

702755 Torque Tester with Adapters

702755-2 T8 / T15 Adaptor

981091 X-Ray Template, Proximal Tibia

Cases and Trays

902955 Metal Base - Instruments902929 Lid for Base - Instruments902930 Instrument Tray 1 (Top)902931 Instrument Tray 2 (Middle)902963 Instrument Tray 3 (Bottom) with space for Locking Insert Forceps Instrumentation902932 Screw Rack902949 Metal Base - Screw Rack902950 Metal Lid for Base - Screw Rack902947 Metal Base - Implants902934 Implant Tray - Proximal Tibia902938 Lid for Base - Proximal Tibia902958 Locking Insert Storage Box 4.0mm

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Tibia Plateau Void Filling

Additional Information

Advantages

Injectable or Manual Implantation

HydroSet can be easily implanted viasimple injection or manual applicationtechniques for a variety of applications.

Fast Setting

HydroSet has been specificallydesigned to set quickly once implantedunder normal physiological conditions,potentially minimizing procedure time.

Isothermic

HydroSet does not release any heat as itsets, preventing potential thermalinjury.

Excellent Wet-FieldCharacteristics

HydroSet is chemically formulated toset in a wet field environmenteliminating the need to meticulouslydry the operative site prior toimplantation.2

Osteoconductive

The composition of hydroxyapititeclosely match that of bone mineralthus imparting osteoconductiveproperties.3

Augmentation of ProvisionalHardware during surgicalprocedure

HydroSet can be drilled and tapped toaccommodate the placement ofprovisional hardware.

Scanning Electron Microscope image ofHydroSet material crystallinemicrostructure at 15000x magnification

HydroSet is an injectable, sculptableand fast-setting bone substitute.HydroSet is a calcium phosphatecement that converts to hydroxyapatite,the principle mineral component ofbone. The crystalline structure andporosity of HydroSet makes it aneffective osteoconductive andosteointegrative material, withexcellent biocompatibility andmechanical properties1. HydroSet wasspecifically formulated to set in a wetfield environment and exhibitsoutstanding wet-field characteristics.2

The chemical reaction that occurs asHydroSet hardens does not release heatthat could be potentially damaging tothe surrounding tissue. Once set,HydroSet can be drilled and tapped toaugment provisional hardwareplacement during the surgicalprocedure. After implantation, theHydroSet is remodeled over time at arate that is dependent on the size of thedefect and the average age and generalhealth of the patient.

Indications

HydroSet is a self-setting calciumphosphate cement indicated to fillbony voids or gaps of the skeletalsystem (i.e. extremities, craniofacial,spine, and pelvis). These defects maybe surgically created or osseous defectscreated from traumatic injury to thebone. HydroSet is indicated only forbony voids or gaps that are notintrinsic to the stability of the bonystructure.

HydroSet cured in situ provides anopen void/gap filler than can augmentprovisional hardware (e.g K-Wires,Plates, Screws) to help support bonefragments during the surgicalprocedure. The cured cement acts onlyas a temporary support media and isnot intended to provide structuralsupport during the healing process.

References1. Chow, L, Takagi, L. A Natural Bone Cement –

A Laboratory Novelty Led to the Development ofRevolutionary New Biomaterials. J. Res. Natl. Stand.Technolo. 106, 1029-1033 (2001).

2. 1808.E703. Wet field set penetration(Data on file at Stryker)

3. Dickson, K.F., et al. The Use of BoneSourceHydroxyapatite Cement for Traumatic MetaphysealBone Void Filling. J Trauma 2002; 53:1103-1108.

HydroSetInjectable HA

Note:For more detailed informationrefer to Literature No. 90-07900

Note:Screw fixation must be providedby bone

Ordering Information

Ref Description397003 3cc HydroSet397005 5cc HydroSet397010 10cc HydroSet397015 15cc HydroSet1275

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Notes

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Notes

Stryker Trauma AGBohnackerweg 1CH-2545 SelzachSwitzerland

www.osteosynthesis.stryker.com

This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or herown professional clinical judgment when deciding whether to use a particular product when treating a particularpatient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of anyparticular product before using it in surgery. The information presented in this brochure is intended to demonstrate aStryker product. Always refer to the package insert, product label and/or user instructions including the instructionsfor Cleaning and Sterilization (if applicable) before using any Stryker products. Products may not be available in allmarkets. Product availability is subject to the regulatory or medical practices that govern individual markets. Pleasecontact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the followingtrademarks or service marks: Stryker, AxSOS, HydroSet.

All other trademarks are trademarks of their respective owners or holders.The products listed above are CE marked.

Literature Number: 982278LOT F1009

US Patents pending

Copyright © 2009 Stryker