The information contained in this documentis intended for healthcare professionals only.

AxSOSTargeting System

•Proximal Lateral Tibia•Alternating Threaded Shaft Holes

Operative Technique

2

Introduction

The AxSOS Locking Plate System is designed to treat periarticular or intra-articular fractures of theProximal Humerus, Distal Femur,Proximal Tibia and the Distal Tibia.The system design is derived based onthe clinical input provided from aninternational panel of experiencedsurgeons, data from current literature,and combined practical andbiomechanical testing.

The anatomical shape, fixed screwtrajectory, and high surface quality ofeach AxSOS plate provides clinicalphysicians the appropriate fixation,adequate fatigue strength, and minimalsoft tissue irritation.

The following Operative Techniquecontains a simple step-by-step procedurefor the implantation of the ProximalLateral Tibial Plate using the speciallydesigned Targeting Device.

3

Features & Benefits

System• The proximal Lateral Tibial Plate is

designed with divergent fixed-angledscrew trajectories in the metaphysealregion and perpendicular fixed-angled screw trajectories in thediaphysis providing improvedbiomechanical stability, essentiallypreventing any loss of reduction.

Instruments• Simple technique with easy to use

instrumentation.

• Designed for MIPO (MinimallyInvasive Plate Osteosynthesis)technique using state of the artinstrumentation.

Range• Longer plates cover a wider range

of fractures.

5 Monoaxial Holes(metaphyseal)• Allow axially stable screw placement,

bringing rigidity to the construct.

Aiming Block• Radiolucent for optimized view

of periarticular region duringfluoroscopy control.

• Facilitates precise placement of metaphyseal Drill Sleeves.

Targeting Arm• Precise fit between targeting holes and

sleeves for accurate screw placement.• Radiolucent for unobstructed

fluoroscopy control.• Optimized view of periarticular

region during fluoroscopy control.

Innovative Locking Screw design• The single thread screw design allows

easy insertion into plate, reducingany potential for cross threading orcold welding.

Frame Fixator• Creates a stable construct between the

Targeting Arm and the plate for exact screw targeting.

Unthreaded Free-Holes• Freehand placement of screws.• Lag Screw capability.

Anatomically contoured• No bending required.• May reduce OR time.• Facilitates/allows for better

soft tissue coverage.• Helps confirm axial alignment.

Kick-Stand Screw• Aimed at posterior/medial fragment

to provide strong triangular fixation.

Shaft Holes Locking orStandard• Pre-threaded Locking Holes allow

axially stable screw placement.• Accept additional Locking Inserts

for improved shaft fixation inosteoporotic bone.

• Neutral fixation using conventional 3.5/4.0mm screws.

Rounded & Tapered Plate End• Helps facilitate sliding of plates

sub-muscularly.

4

Relative Indications & Contraindications

Relative IndicationsThe indications for use of this internalfixation device include metaphyseal extraand intra articular fractures of theproximal Tibia.

Relative ContraindicationsThe physician's education, training andprofessional judgement must be reliedupon to choose the most appropriatedevice and treatment. The followingcontraindications may be of a relative orabsolute nature, and must be taken intoaccount by the attending surgeon:

• Any active or suspected latent infectionor marked local inflammation in orabout the affected area.

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

• Bone stock compromised by disease,infection or prior implantation thatcannot provide adequate supportand/or fixation of the devices.

• Material sensitivity, documented or suspected.

• Obesity. An overweight or obese patientcan produce loads on the implant thatcan lead to failure ofthe fixation of the device or to failure of the device itself.

• Patients having inadequate tissuecoverage over the operative site.

• Implant utilization that would interferewith anatomical structures orphysiological performance.

• Any mental or neuromuscular disorderwhich would create an unacceptablerisk of fixation failure or complicationsin postoperative care.

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

Detailed information is included in the instructions for use being attached toevery implant.

See package insert for a complete list 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 intendedfor screw attachment or fixation to the posterior elements (pedicles) ofthe cervical, thoracic or lumbar spine.

5

Operative TechniqueGeneral Guidelines

Patient PositioningSupine with option to flex the knee.Visualization of the proximal tibia usingfluoroscopy in both the lateral and APviews is necessary.

Surgical ApproachLateral Parapatellar.Lateral curved (hockey stick) or straight.

ReductionAnatomical reduction of the fractureshould be performed either by directvisualization with the help ofpercutaneous clamps, or alternatively by using a bridging external fixator toaid with indirect reduction.

Fracture reduction of the articularsurface should be confirmed by directvision, or fluoroscopy. K-wires can beused as necessary to temporarily securethe reduction. Typically, K-Wires areintended to hold and support reduction,but also to help identify the joint.

Care must be taken that the K-wires donot interfere with the required plate andscrew positions. Also, consideration mustbe taken when positioning independentlag screws prior to plate placement toensure that they do not interfere with theplanned plate location or Locking Screwtrajectories.

If any large bony defects are present theyshould be filled by either bone graft orbone substitute material.

BendingIn most cases the pre-contoured platewill fit without the need for furtherbending.

Plate contouring will affect the abilityto use the Targeting Device forpercutaneous screw placement. Thus,plate contouring is not recommended.

If for any reason the plate needs intra-operative contouring, it isrecommended to perform shaft fixationusing the conventional screw insertiontechnique without the use of theTargeting Device.

6

Operative TechniqueGeneral Guidelines

Ref. 1: Measure off K-Wire

Ref 1A: Measure off Calibration

Ref 1B: Measure off Drill Ref 1D: Measure off Measure Gauge

Ref 1C: Screw Length Control

Screw MeasurementThere are five options to obtain the proper Screw length as illustratedbelow. The Screw Scale (REF 703587)should always be used with theassembled Tissue Protection Sleeve andthe Drill Guides.

Correct Screw SelectionFor metaphyseal fixation, select a screwapproximately 2-3mm shorter than themeasured length to avoid screwpenetrations through the opposite cortex.

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

Soft-Tissue Re-attachmentSpecial undercuts on the reverse side ofthe plate correlating to the two proximalK-Wire holes allow simple passing ofsutures for meniscus re-attachment afterfinal plate fixation.

7

Step 1Pre Operative Planning

Use of the X-Ray Template (REF 981081) in association withfluoroscopy can assist in the selectionof an appropriately sized implant (Fig. 1).

If additional Locking Screws arenecessary, then pre-operative insertionof Locking Inserts is recommended. A4.0mm Locking Insert (REF 370002) isattached to the Locking Insert Inserter(REF 702762) and placed into thechosen hole(s) in the shaft portion ofthe plate (Fig. 2).

Once the Locking Insert is properlyplaced, remove the inserter (Fig. 2A).

Do not place Locking Inserts into theplate with the threaded Drill Sleeve.

Operative Technique

Fig. 1

Locking Insert ExtractorShould removal of a Locking Insert be 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 wish to 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).Discard the Locking Insert.

Fig. 2C

Fig. 2A

B

A

8

Operative Technique

Optional – Intra-OperativeLocking Insert Application

If desired, a Locking Insert can beapplied to a standard hole(s) in the shaft of the plate intra-operativelyby using the Locking Insert Forceps(REF 702968), Centering Pin (REF 702673), Adaptor for CenteringPin (REF 702675) and Guide forCentering Pin (REF 702671) (Ref. 3).

The holes and markings on theTargeting Arm may be used as aguide to locate the respective hole inthe plate.

Using the Tissue Protection Sleeve(REF 703570) and the sharp tip Trocar(REF 703576), can create a small stabincision to separate the soft tissues,which will allow access to the selectedplate hole.

Through the chosen hole, theCentering Pin is inserted using theAdaptor and Guide. It is important touse the Guide (REF 702671) as thiscenters the core hole for Locking Screwinsertion after the Locking Insert isapplied. After inserting the CenteringPin bi-cortically, remove the Adaptorand Guide (Ref. 3B).

Next, place a Locking Insert on the endof the Forceps and slide the instrumentover the Centering Pin down to the hole.

Apply the Locking Insert by triggeringthe forceps handle. Push the button onthe Forceps to remove the device (Ref.3B). Lastly, remove the Centering Pin.

Ref. 3

Ref. 3A

Ref. 3B

9

Operative Technique

Step 2Plate Insertion Handle Assembly

Screw the Connecting Pin (REF 702974)onto the plate using the hex Screwdriver2.5/4.3mm (REF 703592) (Fig. 3A).

Connect the Adaptor Nut (REF 702977)to the Plate Adaptor (REF 703562 /703563) and slide the Plate Adaptor overthe Connecting Pin. Once aligned, andthe teeth engage in the correspondinggrooves in the plate, secure the PlateAdaptor by tightening the Adaptor Nutwith the hex Screwdriver (Fig. 3B).

It is recommended to provisionallyapply the Targeting Arm to check forproper alignment of the TargetingDevice and plate. Insert a Drill throughthe assembled Tissue Protection Sleeveand Drill Sleeve (REF’s 703585, 703570and 703571) into the relevant threadedplate hole prior to plate application.The Targeting Arm can then beremoved again.

The Plate Insertion Handle (REF 702978)can now be attached to help facilitateplate positioning and sliding of longerplates sub-muscularly (Fig. 3).

Step 3 Submuscular Plate Application

When implanting longer plates,a minimally invasive technique can be used.

The Soft Tissue Elevator (REF 702782)is designed to create a pathway for theimplant (Fig. 4).

The implant has a special rounded andtapered end, which further allows forsmooth insertion under the soft tissue.

After a skin incision is made andanatomical reduction is achieved, theplate is applied so that the lateral tibialplateau is supported, with the proximalend of the plate approximately 5mmbelow the articulating surface (Fig. 5).

Essentially, ensuring that the mostproximal Locking Screws are directlysupporting the joint surface.

Fig. 5

Fig. 4

Fig. 3

Fig. 3A Fig. 3B

In addition, End Markers (REF 703568)may be inserted into the appropriateholes of the Targeting Arm to assist inlocating the holes with Locking Insertsand the plate end during the entireprocedure (Fig 6).

Note: A slightly extended distal shaftincision is recommended to visualize the superficial peroneal nerve.In certain cases this nerve crosses thetibia in the proximity of the distal part ofa 12 -14 hole plate.

Step 4Primary Plate Fixation

A K-Wire 2.0 x 285mm (REF 703583)can be inserted through the cannulationof the Adaptor Nut and the PlateAdaptor to help secure the plate to thebone (Fig. 7). Also, other independentlyplaced K-Wires, can help supportdepressed articular surface fragments.Insertion of a K-Wire should be checkedby fluoroscopy to avoid penetration intothe articulating surface.

To remove insertion handle, press themetal button at the top of the handle.

At this point, alignment of the plate tothe shaft of the tibia should be checkedby fluoroscopy in both the AP and lateralplanes, both proximally and distally.

Attach the correct Aiming Block (REF 703564/703565) to the PlateAdaptor. Ensure that the Aiming Block isproperly seated on the Adaptor shaft andsecured with the Aiming Block Screw(Fig. 8).

Using the Tissue Protection Sleeve (REF703578) together with the Drill Sleeve(REF 703571) and the Trocar (REF703577), the Drill Sleeve can be insertedinto the most posterior hole of themetaphyseal portion of the plate.

Ensure that the Drill Sleeve is properlyseated in the thread of the plate hole.

Remove the Trocar, replace it with theK-Wire Sleeve (REF 703575) and theninsert a 2.0 x 285mm K-Wire(REF 703583).

The above step shows the position of aposterior screw, and its relation to thejoint surface. Also, this will confirm thatthe screw is not intra-articularly placed,or too posterior exiting the cortex intothe pupliteal space.

Using fluoroscopy, the K-wire positioncan be checked until the optimal positionis achieved, and the plate is positionedcorrectly.

10

Operative Technique

Fig. 6

Fig. 7

Fig. 8

Also, correct distal placement should bere-confirmed using fluoroscopy to makesure the plate shaft is properly alignedover the lateral surface of the tibial shaft.If the proximal and axial alignment ofthe plate is not achieved, then the K-Wires should be removed, and the plateshould be re-adjusted. The aforesaidprocedure should be repeated until boththe posterior K-Wire and the plate are inthe desired position.

Do not remove K-Wires, as a loss ofplate position could result.

The distal end of the plate must besecured using the most distal hole ofthe shaft.

Attach the Targeting Arm (REF 703566/703567) to the Plate Adaptor.

Mark the skin at the most distal holeusing the Tissue Protection Sleeve (REF703570) and make a small incision.

Insert the Trocar (REF 703576) into theTissue Protection Sleeve (REF 703570)and manipulate the assembly throughthe Targeting Arm and the stab incisionuntil the tip of the Trocar is in contactwith the plate.

Push the Tissue Protection Sleeve furtherinto the hole until the locking notchesfully engage in the corresponding groovein the Targeting Arm (for details see step6 shaft fixation). Ensure that the sleevefixation screw is orientated posteriorly asdisplayed on the Targeting Arm.

Essentially, this will securely lock theTissue Protection Sleeve in theTargeting Arm.

Remove the Trocar and replace it witha Drill Sleeve (REF 703571) and Trocar3.1mm (REF 703577), and continue tomanipulate the assembly into the platehole. Ensure that the Drill Sleeve is fullyengaged in the thread of the plate hole to create a stable construct between theTargeting Arm and the plate, providingsufficient stability for accurate screwtargeting.

Secure the Drill Sleeve by tightening theSleeve Fixation Screw. A 2.0x285mm K-Wire (REF 703583) can now be

inserted using the K-Wire Sleeve (REF 703575) (Fig. 9).

Alternatively, the 3.1mm CalibratedDrill (REF 703585) can be insertedbi-cortically. Additionally, it isrecommended to leave the Drill Bit inplace for primary plate stabilization.

If desired, the plate can be pushed to thebone by using the Frame Fixator (REF703573) instead of the drill or K-Wire.To do so, remove the outer sleeve of thefixator. The self-drilling, self-tapping tipof the Frame Fixator pin should beinserted bi-cortically through the Drill

Sleeve (REF 703571).To confirm bi-cortical purchase use fluoroscopy.

When inserting the pin by power,make sure to use a low-speed to avoidsignificant temperature increase, whichcan lead to bone necrosis.Re-attach the outer sleeve over thethreaded part of the pin and turn thesleeve until the plate is in the desiredposition (Fig. 10).

11

Operative Technique

Fig. 9

Fig. 10

12

Fig. 11

Operative Technique

Using plates with 10 holes or longer, it isrecommended to insert an additionalTissue Protection/Drill Sleeve assemblyin one of the threaded holes in a morecentral position near holes 4 or 6. (Donot lock the Drill Sleeve!) Essentially, thiswill provide additional rigidity to theframe and will help to compensate platedeformity that might occur using astandard cortical screw to push the plateagainst the bone (Fig. 11).

The Frame Fixator can also be used forindirect fracture reduction anywherealong the tibial shaft using the “Pull Reduction Method”.

Step 5Metaphyseal Fixation

Locking Screws cannot act as lag screws.Should an interfragmentary compressioneffect be required in metaphysealfragments, then a 3.5mm standard cortexscrew, or 4.0mm cancellous screw mustfirst be placed in one of the unthreadedmetaphyseal plate holes inferior to thePlate Adapter prior to any placement ofLocking Screws. The sleeve assembly andthe K-Wire in the posterior metaphysealhole should be removed. Freehandplacement of this screw(s) can then beperformed using the free-hand TissueProtection Sleeve 2.5mm (REF 702920)together with the Drill Sleeve (REF703572). Using the Calibrated Drill2.5mm (REF 703586), drill the core holeto the appropriate depth (Fig. 12).

The Screw length can directly be read offthe Calibrated Drill by using the ScrewScale (REF 703587) as described underthe Measurement Options on page 6.Over-drill the first cortex using the3.5mm (REF 703590) through the TissueProtection Sleeve. A fully threadedcortical screw can then be insertedthrough the Tissue Protection Sleeve.If inserting a 4.0mm cancellous screw,the near cortex should be pre-tappedusing the Tap (REF 703589 optional).Care must always be taken, that thesescrews do not interfere with the LockingScrew trajectories.

Fig. 12

Locking Fixation of the metaphysealportion of the plate can now begin.Again, re-attach and tighten the AimingBlock to the Plate and insert the TissueProtection Sleeve and the Drill Sleeveinto the most posterior metaphyseallocking screw hole. Drill the core holefor the Locking Screw using a 3.1mmdrill (REF 703585).

Using fluoroscopy, check the correctdepth of the drill. The screw length canbe checked with a direct read off thecalibrated drill, or any other measurementoption as described on page 6.Remove the drill and drill sleeve, andinsert the correct length 4.0mm LockingScrew using the screwdriver T15 (Ref703594). (Fig. 13)

Final seating position of the screw occurswhen the groove around the shaft of theScrewdriver is approaching the end ofthe Tissue Protection Sleeve.

Locking Screws should initially be insertedmanually to ensure proper alignment.

If the Locking Screw thread does notimmediately engage the plate thread,reverse the screw a few turns and re-insert the screw for proper alignment.

13

Operative Technique

Fig. 13

Final tightening of Locking Screwsshould always be performed manuallyusing the Torque Limiting Attachment(REF 702750) together with theScrewdriver Bit T15 (REF 703595) and the T-Handle (REF 702427) (Fig. 14).

The Torque Limiter helps prevent over-tightening of Locking Screws, and alsoensures that screws are tightened to atorque of 4.0Nm. The device will clickwhen the torque reaches 4Nm.

If inserting Locking Screws under power,make sure to use a low speed drill settingto avoid damage to the screw/plateinterface. Perform all final tightening byhand, as described above.

The remaining proximal Locking Screwsare inserted following the sametechnique with or without the use of K-Wires.Remove K-Wire in the plate adaptorbefore inserting subsequent metaphysealscrews to avoid interference with thedrill/screws.

To ensure maximum stability, it isrecommended that all locking holes be filled with a Locking Screw of theappropriate length.

However, it is recommended to place the Kick-Stand screw only aftercompletion of all shaft fixation.

14

Operative Technique

Fig. 14

Step 6 Shaft Fixationa) Standard Screws

Standard cortical screws in the shaftmust be placed prior to any LockingScrews.

Mark the chosen standard shaft holeusing the Tissue Protection Sleeve andTrocar with sharp tip to create a smallincision. Insert the Tissue ProtectionSleeve (REF 703570) together with theTrocar (REF 703576) until the tip is incontact with the plate (Fig. 15).

Push the Tissue Protection Sleeve furtheruntil you hear a click, confirming thatthe sleeve has snapped into position(Fig. 16).

Remove the Trocar and replace it with the Drill Sleeve (REF 703572).Insert the 2.5mm Trocar (REF 703584),and manipulate the assembly into theplate hole. Lock the Drill Sleeve andremove the Trocar (Fig. 17).

The Calibrated Drill 2.5mm (REF 703586)is then used to drill the core hole for the3.5mm cortical screw (Fig. 18).

Drill through both cortices for bi-corticalscrew fixation. If lagging is desired,remove the drill guide after drilling thecore hole, and over-drill the first cortexusing the drill 3.5mm (REF 703590).The screw length can be determined witha direct read off the calibrated drill, orany other measurement option asdescribed on page 6. Remove the DrillSleeve. The appropriate size self-tappingcortical screw is inserted using the hexScrewdriver (REF 703592), or theScrewdriver Bit (REF 703593) shouldpower insertion be desired (Fig. 19).

In hard cortical bone, is is recommendedto use the Tap 3.5mm (REF 703588optional) before screw insertion.Repeat the same procedure for otherchosen unthreaded shaft holes.

15

Operative Technique

b) Locking Screws

4.0mm Locking Screws can be placed inthe threaded shaft holes, or holes withpre-placed Locking Inserts. For theplacement of these screws, follow thesame procedure detailed in step (a)Standard Screws.For Locking Screws use appropriateinstrumentation outlined below:

- Drill Sleeve 3.1mm (REF 703571)- Trocar 3.1mm (REF 703577)- Calibrated Drill 3.1mm (REF 703585)- Screwdriver T15 (REF 703594)- Screwdriver Bit T15 (REF 703595)- Tap Locking (REF 703574)

Remove Targeting Arm.

Fig. 15 Fig. 16

Fig. 17 Fig. 18

Fig. 19

Step 7 Kick-Stand Screw Placement

The oblique ‘Kick-Stand’ Locking Screwprovides strong triangular fixation to themedial metaphyseal fragments. It isrecommended to insert the kick standscrew after shaft fixation is complete.

Re-attach the Aiming Block and insertthe necessary Sleeves for 4.0mm LockingScrew insertion, as described before(Fig. 20).

It is advised to place the screw with theassistance of fluoroscopy to prevent jointpenetration and impingement with othermetaphyseal Screws (See Step 5 for insertion guidelines).

Remove all targeting attachments.

Final plate and screw positions areshown in Figures 21–23.

16

Operative Technique

Fig. 20

Fig. 23Fig. 22Fig. 21

17

Tips & Tricks

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

Free hand drilling will lead to amisalignment of the screw, resulting inscrew jam during insertion. It is essentialto drill the core hole in the correcttrajectory to facilitate accurate insertionof the Locking Screws.

If the Locking Screw thread does notimmediately engage the plate thread,reverse the screw a few turns and re-insert the screw once it is properly aligned.

2. Always start inserting the screwmanually to ensure proper alignmentin the plate thread and the core hole.Also, it is recommended to startinserting the screw using “the twofinger technique” on the Teardrophandle. Avoid any angulation orexcessive force on the screwdriver, asthis could cross-thread the screw.

Power can negatively affect Screwinsertion, if used improperly, damagingthe screw/plate interface (screwjamming). As a result, this can lead toscrew heads breaking or stripping.

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

3. If power insertion is selected after manualstart (see above), apply slow speed only,do not force axial pressure, and never“push” the screw through the plate!

Allow the single, continuous threadscrew design to engage the plate and cutinto the bone.

Stop power insertion approximately1cm before engaging the screw head intothe plate.

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

5. Do not use power for final insertion ofLocking Screws. It is imperative toengage the screw head into the plateusing the Torque Limiting Attachment.Ensure that the screwdriver tip is fullyseated in the screw head, but do notapply axial force during final tightening.

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

The spherical tip of the Tap preciselyaligns the instrument in the predrilledcore hole during thread cutting.Essentially, this facilitates subsequentscrew placement.

18

Ordering Information - Targeting Instruments

REF Description

902845 Metal Tray Prox. Lat.Tibia Targeting Instruments

1806-9000 Universal Metal Lid for Tray

702974 Connecting Pin - Prox. Lat. Tibia

703562 Plate Adapter - Prox. Lat. Tibia, left

703563 Plate Adapter - Prox. Lat. Tibia, right

702977 Adapter Nut - Prox. Lat. Tibia

703564 Aiming Block - Prox. Lat. Tibia, left

703565 Aiming Block - Prox. Lat. Tibia, right

703597 Aiming Block Screw

703566 Targeting Arm - Prox. Lat. Tibia, left

703567 Targeting Arm - Prox. Lat. Tibia, right

703568 Plate End Marker

19

Ordering Information - 4.0mm Instruments

REF Description

902846 Metal Tray Instruments

1806-9000 Universal Metal Lid for Tray

703592 Screwdriver HEX 2.5/4.3mm

703593 Screwdriver Bit HEX 2.5/4.3mm, small AO

703594 Screwdriver T15

703595 Screwdriver Bit T15, small AO

703585 Calibrated Drill Bit 3.1x285mm, small AO

703586 Calibrated Drill Bit 2.5x285mm, small AO

703587 Screw Scale

703573 Frame Fixator

703570 Tissue Protection Sleeve, centric

703591 Sleeve Fixation Screw

703578 Tissue Protection Sleeve, Aiming Block

703571 Drill Sleeve 3.1mm

703572 Drill Sleeve 2.5mm

703575 K-Wire Sleeve

703577 Trocar 3.1mm

703584 Trocar 2.5mm

703576 Trocar sharp Tip

703574 Tap 4.0mm Locking

703583 K-Wire with Drill Tip 2.0x285mm

703579 Screw Measure Gauge

703590 Drill 3.5mm, small AO

702978 Plate Insertion Handle

702920 Tissue Protection Sleeve, free hand

702750 4Nm Torque Limiter

20

Ordering Information - 4.0mm Instruments

REF Description

702762 Locking Insert Inserter

702767 Locking Insert Extractor

702782 Soft Tissue Elevator

702427 Small T-Handle, AO Coupling

Optional Instruments

702968 Locking Insert Forceps

702673 Centering Pin

702675 Adaptor for Centering Pin

702671 Guide for Centering Pin

703580 Screwdriver Hex 2.5mm, self retaining

703581 Screwdriver T15, self retaining

703588 Tap 3.5mm, cortical

703589 Tap 4.0mm, cancellous

21

Ordering Information - Implants

Stainless Steel Plate Shaft Locking LockingREF Length Holes Holes Holes

Left Right mm Metaphyseal Shaft

437302 437322 95 2 5 1437304 437324 121 4 5 2437306 437326 147 6 5 3437308 437328 173 8 5 4437310 437330 199 10 5 5437312 437332 225 12 5 6437314 437334 251 14 5 7

Stainless Steel SystemREF mm

370002 4.0

PROXIMAL LATERAL TIBIA Locking Screws 4.0mm Standard Screws 3.5, 4.0mm

4.0MM LOCKING INSERT

Note: For Sterile Implants, add ‘S’ to REF

22

Stainless Steel ScrewREF Length mm

370514 14370516 16370518 18370520 20370522 22370524 24370526 26370528 28370530 30370532 32370534 34370536 36370538 38370540 40370542 42370544 44370546 46370548 48370550 50370555 55370560 60370565 65370570 70370575 75370580 80370585 85370590 90370595 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 TAPPING T15 DRIVE

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

Ordering Information - Implants

4.0MM CANCELLOUS SCREW, PARTIALLY THREADED2.5MM HEX DRIVE

4.0MM CANCELLOUS SCREW, FULLY THREADED2.5MM HEX DRIVE

Note: For Sterile Implants, add ‘S’ to REF

Indications

HydroSet is a self-setting calciumphosphate cement indicated to fill bonyvoids or gaps of the skeletal system (i.e.,extremities, craniofacial, spine, andpelvis). These defects may be surgicallycreated or osseous defects created fromtraumatic injury to the bone. HydroSet isindicated only for bony voids or gapsthat are not intrinsic to the stability ofthe bony structure.

HydroSet cured in situ provides an openvoid/gap filler than can augment provisional hardware (e.g K-Wires,Plates, Screws) to help support bonefragments during the surgical procedure.The cured cement acts only as atemporary support media and is notintended to provide structural supportduring the healing process.

HydroSet is an injectable, sculptable andfast-setting bone substitute. HydroSet isa calcium phosphate cement thatconverts to hydroxyapatite, the principlemineral component of bone. Thecrystalline structure and porosity ofHydroSet makes it an effectiveosteoconductive and osteointegrativematerial, with excellent biocompatibilityand mechanical properties.1 HydroSetwas specifically formulated to set in awet field environment and exhibitsoutstanding wet-field characteristics.2

The chemical reaction that occurs asHydroSet hardens does not release heatthat could be potentially damaging to thesurrounding tissue. Once set, HydroSetcan be drilled and tapped to augmentprovisional hardware placement duringthe surgical procedure. Afterimplantation, HydroSet is remodelledover time at a rate that is dependent onthe size of the defect and the average ageand general health of the patient.

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 specifically designedto set quickly once implanted undernormal physiological conditions,potentially minimizing procedure time.

Isothermic

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

Excellent Wet-Field Characteristics

HydroSet is chemically formulated to setin a wet field environment eliminatingthe need to meticulously dry theoperative site prior to implantation.2

Osteoconductive

The composition of hydroxyapatiteclosely match that of bone mineral thusimparting osteoconductive properties.3

Augmentation of ProvisionalHardware during surgicalprocedures

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

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.

23

Tibia Plateau Void Filling

Additional InformationHydroSet Injectable HA

Scanning Electron Microscope image of HydroSet materialcrystalline microstructure at 15000x magnification

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

Ordering Information

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

Note: Screw fixation must be provided by bone

Joint Replacements

T rauma, Ext r emities & Deformities

Craniomaxillofacial

Spine

Biologics

Surgical P r oducts

Neu r o & ENT

Inte r ventional Pain

Navigation

Endoscopy

Communications

Imaging

Patient Handling Equipment

EMS Equipment

Joint Replacements

T rauma, Ext r emities & Deformities

Craniomaxillofacial

Spine

Biologics

Surgical P r oducts

Neu r o & ENT

Inte r ventional Pain

Navigation

Endoscopy

Communications

Imaging

Patient Handling Equipment

EMS Equipment

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www.stryker.com

A surgeon must always rely on his or her own professional clinical judgment when deciding to use whichproducts and/or techniques on individual patients. Stryker is not dispensing medical advice and recommendsthat surgeons be trained in orthopaedic surgeries before performing any surgeries.

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 practicesthat govern individual markets. Please contact your Stryker representative if you have questions about theavailability 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: AxSOS, Stryker.

Literature Number: LAXTS-OTMS/GS 1.5M 07/07

Copyright © 2007 StrykerPrinted in USA