SURGICAL TECHNIQUEIntegra® CONSTRUCT™ Ankle Fusion Plating System

Table of Contents

IntroductionIndications .............................................................................................................................................................................................................2Contraindications .................................................................................................................................................................................................2System Features and Benefits ...........................................................................................................................................................................2

Anterior Ankle Fusion Surgical Technique – Primary Ankle FusionStep 1: Incision & Preparation of Joint Surfaces .............................................................................................................................................. 3Step 2: Plate Placement ......................................................................................................................................................................................4Step 3: Insertion of Talus Screws .......................................................................................................................................................................4Step 4: Compression Using Tibial Screws ........................................................................................................................................................ 5Step 5: Closure ......................................................................................................................................................................................................6

Lateral TTC Fusion Surgical TechniqueStep 1: Incision & Preparation of Joint Surfaces .............................................................................................................................................. 7Step 2: Plate Selection ........................................................................................................................................................................................ 7Step 3: Targeting Guide Assembly ..................................................................................................................................................................... 7Step 4: Insertion of the Calcaneal Screws ........................................................................................................................................................8Step 5: Anterior Screw Insertion ........................................................................................................................................................................9Step 6: Proximal Screw Placement .................................................................................................................................................................. 10Step 7: Proximal Screw Placement ................................................................................................................................................................... 10Step 8: Closure .................................................................................................................................................................................................... 10

Instrument Tray ................................................................................................................................................................................................... 11Ordering Information ........................................................................................................................................................................................ 12Essential Product Information .......................................................................................................................................................................... 14

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System Features and Benefits

Indications

Contraindications

*ESSENTIAL PRODUCT USE INFORMATION: For additional important information pertaining to the use of this product, please see product package insert. This information was current at the time of printing, but may have been revised after that date.

The CONSTRUCT ™ Ankle Fusion Plate System is intended for the following:• Arthrodesisoftheanklejointandtibia• Fractures,osteotomies,fusions,andreplantationsofsmallbonesinthefootandankle.

• Notindicatedforfixationtotheposteriorelementsofthecervical,thoracic,orlumbarspine.• Screwsarecontraindicatedin:activeinfection,conditionswhichtendtoretardhealingsuchasbloodsupplylimitations,

previous infections, insufficient quantity or quality of bone to permit stabilization of the fracture complex, conditions that restrict the patient’s ability or willingness to follow postoperative instructions during the healing process and foreign body sensitivity.

• Caseswithmalignantprimaryormetastatictumorswhichprecludeadequatebonesupportorscrewfixations, unless supplemental fixation or stabilization methods are utilized.

• Foreignbodysensitivity–wherematerialsensitivityissuspected,appropriatetestsshouldbemadeandsensitivityruledout prior to implementations.

• Theseimplantsareintendedasaguidetonormalhealing,andareNOTintendedtoreplacenormalbodystructureorbearthe weight of the body in the presence of incomplete bone healing. Delayed unions or non-unions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All metal surgical implants are subjectedtorepeatedstressinuse,whichcanresultinmetalfatigue.

See package insert for full prescribing information.*

• Anatomicanteriorandlaterallockingplatesinonesetforsurgicalflexibility• Reconstructionplateoptionsforspanningandfixatinggraftsduringrevisioncases• Plateholesaccommodate4.5&6.5mmlockingandcompressionscrewsforrigidfixation• Interfragmentscrewtargetingguideattachestolateralplateforidealplacementwithoutinterferenceoflocking

plate screws• Anteriorplatepreservestheposteriorhingeallowingevenjointcompressionandstability• Jointcompressioncanbeachievedthroughtheplateforanidealfusionsite

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Step 1 • Incision & Preparation of Joint SurfacesAskinincisionismadedirectlyanteriortotheanklejoint,bisecting the medial and lateral malleoli. Deepen the skin incision only to the subcutaneous layer, identifying and protecting the superficial peroneal nerve and its crossing branches where possible.

Identify the plane between the tibialis anterior and the EHL tendons. Incise the extensor retinaculum in this plane. Be aware that the neurovascular bundle lies between these structuresproximaltotheanklejoint.Retractthetibialisanterior tendon medially and divide the deeper soft tissues andanklecapsuledirectlytobone,justlateraltothebedof the tibialis anterior. A vascular leash of vessels is usually encounteredanteriortotheanklejointproper,andelectriccautary is usually necessary. Subperiostally dissect the soft tissues off the anterior distal tibia and talar neck until the medial and lateral malleoli are well visualized.

Take care to place no undo tension on the skin or the soft tissuesanteriortotheanklejoint.Manualretractionispreferred, but deep self-retaining retractors (such as gelpy retractors) avoiding tension of the skin, may be acceptable.

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Anterior Ankle Fusion Surgical Technique – Primary Ankle Fusion

As the manufacturer of this device, Integra LifeSciences Corporation does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and using the appropriate technique in each patient.

Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner.

Using an osteotome or saggital saw, remove any anterior osteophytes, including the anterior malleolus until there is no anterior prominence. The roof of the distal tibial articular surface is then well visualized, and there is no overhang of the distal tibia, relative to the anterior cartilaginous surface of the talus. Also remove any osteophytes or bony prominences overthedistalaspectofthetalusjustproximaltothetalonavicularjoint.

Remove the cartilage and subchondral bone from the distal tibia and talar dome, taking care to preserve the posterior malleolus and posterior capsule. The cartilage may be removed from the posterior malleolus, but to maintain a posterior hinge, the bone and soft tissue should be preserved. Using an osteotome or reciprocating saw, the cartilaginous surfaces of the medial and lateral gutter are removed to ensure there are no restrictions to proper positioning. Take care not to violatethesubtalarjointwiththecuts.Usingasmallosteotome,featherbothjointsurfacestoensurenosubchondralsurfacesremain.Packtheanklejointfirmlywiththesurgeon’sbonegraftofchoicetoensurecontinuouscontactwithbone or bone graft between the fusion surfaces.

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Step 2 • Plate Placement

AFP-A07RT Right Anterior Ankle Fusion Plate, 7 Hole

AFP-A09RT Right Anterior Ankle Fusion Plate, 9 Hole

AFP-A07LT Left Anterior Ankle Fusion Plate, 7 Hole

AFP-A09LT Left Anterior Ankle Fusion Plate, 9 Hole

Firmly dorsiflex the foot to a neutral position. Select and apply the proper plate to the anterior ankle. Check that the plate sits flush on the anterior tibia and talar neck, ensuring that there is notananterioroverhangontothetalonavicularjoint.ThePFPinor K-wires may be applied to the tibia, taking care not to fix the plate to the anterior tibia at this time.

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PF Pin

Double Drill Guide and 3.2 mm Drill Bit

Rachet Driver

4.5 mm Locking Drill Guide and 3.2 mm Drill Bit

Step 3 • Insertion of Talus ScrewsUsing the red sleeve on the double-sided Double Drill Guide and the 3.2 mm Drill Bit, drill the most proximal screw hole on thetalarlimb.Takecarenottoviolatethesubtalarjointwiththe drill or the screw.

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Use the Depth Gauge to select the appropriate 4.5 mm Compression Screw to compress the plate to the talar neck. At this time, check a lateral radiograph to ensure the plate is sitting appropriately to the talar neck, and the long axis of the ankle is parallel to the plate. If the plate appears appropriate, place the remaining two locking screws in the talus.

Screw the 4.5 mm Locking Drill Guide into the distal hole. Use the 3.2 mm Drill Bit and take care not to violate the subtalarjoint.

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Step 4 • Compression Using Tibial ScrewsProperly align the foot in dorsiflexion/plantarflexion and varus/valgus. Place the Compression Drill Guide in the more distal oblong hole. The 3.2 mm Drill Bit should be placed further away from the fusion site, with the compression arrow oriented proximally.

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6.5 mm gold Locking Drill Guide & 5.0 mm Drill Bit

Compression Drill Guide & 3.2 mm Drill Bit

Use the Depth Gauge to select the appropriate 4.5 mm Locking Screw. Insert the screw until fully seated and threaded into the plate.

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Repeat this process to fill the lateral talar body screw with a 6.5 mm Locking Screw, utilizing the 6.5 mm gold Locking Drill Guide and the 5.0 mm Drill Bit.

Once again, assure the screw is fully seated into the plate.

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Step 5 • ClosureClosure should be performed in a layered fashion after hemostasis is achieved. Care should be taken to close the extenser retinaculum.

Perform drilling and use the Depth Gauge to measure for the placement of a bicortical non-locking screw to further compressthejoint.Insertthescrewuntilfullyseatedandjointcompression is visualized.

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Repeat this process in the proximal lateral oblong hole, remembering to loosen the first tibial screw placed prior to compression with the second screw. Use the Locking Drill Guide to drill for the final two locking screws.

For the use of a 4.5 mm Locking Screw, thread the 4.5 mm Locking Drill Guide into the screw hole. Attach the 3.2 mm Drill Bit to power and advance the drill through the guide until the appropriate depth is reached. Remove the Drill Guide and insert the Depth Gauge to determine the appropriate size screw.

For the use of a 6.5 mm Locking Screw, thread the 6.5 mm Locking Drill Guide into the screw hole. Attach the 5.0 mm Drill Bit to power and advance the drill through the guide until the appropriate depth is reached. Remove the Drill Guide and use the Depth Gauge to determine the appropriate size screw.

The plate is now fixated, and closure can be performed.

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Fibular Resection

Step 1 • Incision & Preparation of Joint Surfaces

Step 2 • Plate Selection

Step 3 • Targeting Guide Assembly

Using a surgical marker, outline the boundaries of the fibula. Place the appropriate lateral ankle fusion plate on the skin to estimate the exposure necessary for positioning. An extensile lateral approach is taken down to bone to the distal tip of the fibula, proceeding distally to create a calcaneal flap.

Select the corresponding lateral fusion plate. The plate is anatomically pre-contoured to fit the anatomy of the TTC.

Place the correlating Targeting Base over the proximal 2 mm diameter threaded hole with the sleeve positioned anteriorly. Thread the Targeting Base Knob (GTB-1000-03) through the guide and into the plate.

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Lateral TTC Fusion Surgical Technique

As the manufacturer of this device, Integra LifeSciences Corporation does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and using the appropriate technique in each patient.

Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner.

The peroneal tendons are usually sacrificed to decompress the area and allow for better soft tissue coverage. The fibula is osteotomized at an angle to prevent a prominent edge,justproximaltothemostproximalportionoftheplate. An osteotome is used to aid in removal of the fibula and to prepareaflatsurfacealongthelateralTTCjointsfortheplatetositflush.TheTTCjointsarepreparedforarthrodesispersurgeon preference. The excised fibula can be used as bone graft.

AFP-L09RT Right Lateral Ankle Fusion Plate, 9 Hole

AFP-L09LT Left Lateral Ankle Fusion Plate, 9 Hole

GTB-1000-01Guide Pin Targeting Base,

Left (Red)

GTB-1000-02Guide Pin Targeting Base,

Right (Green)

TipThe targeting guide is properly placed when the proximal two tibial holes are completely covered by the guide and the distal two tibial holes are visualized.

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Step 4 • Insertion of the Calcaneal ScrewsIn order to maintain rotational stability and assure the interfragmentary screw does not impede on plate screws, fixating the distal portion of the plate is recommended prior to insertion of the interfragmentary anterior compression screw. The use of 4.5 mm or 6.5 mm locking and non-locking screws is surgeon preference and varies based upon patient anatomy and disease state. However, using a non-locking screw first is recommended to compress the plate to bone.

For the use of non-locking 4.5 mm (shown) or 6.5 mm screws, use the 3.2 mm side of the Double Drill Guide. Place the guide into the screw hole for 15° of variability. Once the proper angle has been determined, insert the 3.2 mm Drill Bit through the guide until adequate depth is achieved.

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3- 1The Targeting Guide can be used as a handle during plate placement. Place the plate onto the lateral surface so that the distal four holes align with the calcaneus, the single middle hole aligns with the talus, and the proximal four holes are aligned with the tibia. Temporary fixation is achieved by inserting the PF Pins through the distal two tibia plate holes for rotational stability during interfragmentary screw placement.

Targeting Guide & PF Pins

Double Drill Guide & 3.2 mm Drill Bit

6.5 mm Locking Drill Guide & 5.0 mm Drill Bit

TX-25 Torx Driver

Remove Drill Guide and insert the Depth Gauge to determine the correct size screw. Insert the correlating non-locking screw using the TX-25 Torx Driver until the screw is seated.

Once the plate is compressed to the calcaneus, insertion of locking screws may be performed. For the use of a 6.5 mm Locking Screw (shown), thread the 6.5 mm Locking Drill Guide into the screw hole. Attach the 5.0 mm Drill Bit to power and advance the drill through the guide until the appropriate depth is reached.

Remove Drill Guide and use the Depth Gauge to determine the appropriate size screw. Select the correlating 6.5 mm Locking Screw and drive until the screw is fully seated into the plate using the TX-25 Torx Driver. Continue with the insertion of the remaining two calcaneal holes.

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Optional Cannulated Countersink/Depth Gauge

Step 5 • Anterior Screw Insertion

Optional CAPTURE 7.0 mm High-Torque Cannulated Screw Placement

With the plate fixed to the calcaneus with screws and to the tibiawithPFPins,compressionoftheTTCjointmaybeachievedusing a 6.5 mm Compression Screw. Slide the Guide Pin Targeting Sleeve into the Targeting Base slot and advance the thread until seated. Insert the 3.2 mm Long Drill Bit through the Guide Pin Targeting Sleeve until appropriate depth is achieved in the calcaneus, making a stab incision at the entry point of the drill, or by moving the skin flap over the anterior tibia.

After assembly of Targeting Base, insert a 3.2 mm Guide Pin from the CAPTURE 7.0 mm High-Torque System through the Guide Pin Targeting Sleeve until appropriate depth is achieved in the calcaneus, making a stab incision at the entry point of the Guide Pin, or by moving the skin flap over the anterior tibia. Remove the Targeting Sleeve. Place the cannulated Countersink/Depth Gauge over the Guide Pin and rotate back and forth until countersink depth is achieved. Determine the appropriate size screw based upon the Depth Gauge reading. Select the correlating screw and place it over the Guide Pin. Advance the screw using the driver until the screw head is slightly proud of the anterior tibia. At this point, the PF Pins areloosenedtoallowforcompressionoftheTTCjoint. The screw is now seated and compression is achieved. Placement of the screw is confirmed with fluoroscopy. The targeting guide assembly is now removed and the PF Pins can be re-seated for stability.

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Remove the Targeting Sleeve. Place the Countersink w/AO Quick Connect through the Targeting Base until countersink depth is achieved. Determine the appropriate size screw by inserting the Depth Gauge for Plate Screws into the drill hole. Advance the corresponding screw using the driver until the screw head is slightly proud of the anterior tibia. At this point, the PF Pins are loosened to allow for compression oftheTTCjoint.Thescrewisnowseatedandcompressionis achieved. Placement of the screw is confirmed with fluoroscopy. The targeting guide assembly is now removed and the PF Pins can be re-seated for stability.

NoteCAPTURE High-Torque Cannulated Screws are provided in a separate instrument set.

Guide Pin Targeting Sleeve & 3.2 mm Long Drill Bit

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Step 6 • Proximal Screw Placement

Step 7 • Proximal Screw Placement

Step 8 • Closure

The tibial holes may now be fixated using locking and non-locking screws. For the use of a 4.5 mm Locking Screw, thread the 4.5 mm Locking Drill Guide into the screw hole. Attach the 3.2 mm Drill Bit to power and advance the drill through the guide until the appropriate depth is reached. Remove the Drill Guide and insert the Depth Gauge to determine the appropriate size screw. Select the correlating 4.5 mm Locking Screw and drive until the screw is seated into the plate using the TX-25 Torx Driver. If using non-locking screws, bicortical fixation is recommended.

Thread the 6.5 mm Locking Drill Guide into the plate hole that aligns with the talus. Insert the 5.0 mm Drill Bit through the guide to the appropriate depth. Remove the Drill Guide and insert the screw Depth Gauge to determine the appropriate size screw. Remove the 6.5 mm Locking Screw from the caddy and insert using the TX-25 Torx Driver until the screw is seated into the plate.

Closure is performed per standard protocol.

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6- 2Proceed using the technique for locking and non-locking screws as necessary until the proximal four holes are utilized, removing the PF Pins as needed.

The plate is now fixated and any soft tissue repairs may be performed.

4.5 mm Locking Drill Guide & 3.2 mm Drill Bit

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CONSTRUCT™ Ankle Fusion Plating System – Instrument Tray

1. Drill Bits

2. Left Lateral Plate

3. Right Lateral Plate

4. Left Anterior Plates

5. Right Anterior Plates

6. Left Guide Pin Targeting Base

7. Targeting Base Knobs

8. Guide Pin Targeting Sleeves

9. Right Guide Pin Targeting Base

10. Double Drill Guide

11. Compression Drill Guide

12. Ratchet Driver Handle

13. Osteotome

14. Depth Gauge

15. TX 25 Driver Shaft

16. Large PF Pin

17. Locking Drill Guides

18. AO to Trinkle Adapter

19. Screw Holding Forceps

20. Countersink

21. Drill Bits

22. 2.0mm Guide Pins

23. 4.5mm Compression Screws

24. 4.5mm Locking Screws

25. 6.5mm Compression Screws

26. 6.5mm Locking Screws

1

11

2

10

12

13

4

14

5

15

3

16

17

1819

21

22

23

24

25

26 20

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7

8

9

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Catalog Number

Catalog Number

Catalog Number

Plates

4.5 mm Screws

6.5 mm Screws

AFP-L09RT Right Lateral Ankle Fusion Plate, 9 HoleAFP-L09LT Left Lateral Ankle Fusion Plate, 9 HoleAFP-A07RT Right Anterior Ankle Fusion Plate, 7 HoleAFP-A07LT Left Anterior Ankle Fusion Plate, 7 HoleAFP-A09RT Right Anterior Ankle Fusion Plate, 9 HoleAFP-A09LT Left Anterior Ankle Fusion Plate, 9 Hole

PSS-4514CT 4.5mm Compression Screw, 14mmPSS-4516CT 4.5mm Compression Screw, 16mmPSS-4518CT 4.5mm Compression Screw, 18mmPSS-4520CT 4.5mm Compression Screw, 20mmPSS-4522CT 4.5mm Compression Screw, 22mmPSS-4524CT 4.5mm Compression Screw, 24mmPSS-4526CT 4.5mm Compression Screw, 26mmPSS-4528CT 4.5mm Compression Screw, 28mmPSS-4530CT 4.5mm Compression Screw, 30mmPSS-4532CT 4.5mm Compression Screw, 32mmPSS-4534CT 4.5mm Compression Screw, 34mmPSS-4536CT 4.5mm Compression Screw, 36mmPSS-4538CT 4.5mm Compression Screw, 38mmPSS-4540CT 4.5mm Compression Screw, 40mmPSS-4545CT 4.5mm Compression Screw, 45mmPSS-4550CT 4.5mm Compression Screw, 50mmPSS-4555CT 4.5mm Compression Screw, 55mmPSS-4560CT 4.5mm Compression Screw, 60mmPSS-4565CT 4.5mm Compression Screw, 65mmPSS-4570CT 4.5mm Compression Screw, 70mmPSS-4575CT 4.5mm Compression Screw, 75mmPSS-4580CT 4.5mm Compression Screw, 80mm

PSS-4514LT 4.5mm Locking Screw, 14mmPSS-4516LT 4.5mm Locking Screw, 16mmPSS-4518LT 4.5mm Locking Screw, 18mmPSS-4520LT 4.5mm Locking Screw, 20mmPSS-4522LT 4.5mm Locking Screw, 22mmPSS-4524LT 4.5mm Locking Screw, 24mmPSS-4526LT 4.5mm Locking Screw, 26mmPSS-4528LT 4.5mm Locking Screw, 28mmPSS-4530LT 4.5mm Locking Screw, 30mmPSS-4532LT 4.5mm Locking Screw, 32mmPSS-4534LT 4.5mm Locking Screw, 34mmPSS-4536LT 4.5mm Locking Screw, 36mmPSS-4538LT 4.5mm Locking Screw, 38mmPSS-4540LT 4.5mm Locking Screw, 40mmPSS-4545LT 4.5mm Locking Screw, 45mmPSS-4550LT 4.5mm Locking Screw, 50mmPSS-4555LT 4.5mm Locking Screw, 55mmPSS-4560LT 4.5mm Locking Screw, 60mmPSS-4565LT 4.5mm Locking Screw, 65mmPSS-4570LT 4.5mm Locking Screw, 70mmPSS-4575LT 4.5mm Locking Screw, 75mmPSS-4580LT 4.5mm Locking Screw, 80mm

PSS-6530CT 6.5mm Compression Screw, 30mmPSS-6532CT 6.5mm Compression Screw, 32mmPSS-6534CT 6.5mm Compression Screw, 34mmPSS-6536CT 6.5mm Compression Screw, 36mmPSS-6538CT 6.5mm Compression Screw, 38mmPSS-6540CT 6.5mm Compression Screw, 40mmPSS-6545CT 6.5mm Compression Screw, 45mmPSS-6550CT 6.5mm Compression Screw, 50mmPSS-6555CT 6.5mm Compression Screw, 55mmPSS-6560CT 6.5mm Compression Screw, 60mmPSS-6565CT 6.5mm Compression Screw, 65mmPSS-6570CT 6.5mm Compression Screw, 70mmPSS-6575CT 6.5mm Compression Screw, 75mmPSS-6580CT 6.5mm Compression Screw, 80mm

PSS-6520LT 6.5mm Locking Screw, 20mmPSS-6522LT 6.5mm Locking Screw, 22mmPSS-6524LT 6.5mm Locking Screw, 24mmPSS-6526LT 6.5mm Locking Screw, 26mmPSS-6528LT 6.5mm Locking Screw, 28mmPSS-6530LT 6.5mm Locking Screw, 30mmPSS-6532LT 6.5mm Locking Screw, 32mmPSS-6534LT 6.5mm Locking Screw, 34mmPSS-6536LT 6.5mm Locking Screw, 36mmPSS-6538LT 6.5mm Locking Screw, 38mmPSS-6540LT 6.5mm Locking Screw, 40mmPSS-6545LT 6.5mm Locking Screw, 45mmPSS-6550LT 6.5mm Locking Screw, 50mmPSS-6555LT 6.5mm Locking Screw, 55mmPSS-6560LT 6.5mm Locking Screw, 60mmPSS-6565LT 6.5mm Locking Screw, 65mmPSS-6570LT 6.5mm Locking Screw, 70mmPSS-6575LT 6.5mm Locking Screw, 75mmPSS-6580LT 6.5mm Locking Screw, 80mm

Description

Description

Description

13

Catalog Number

Catalog Number

Instruments

Disposables

LDG-5010-45 4.5mm Locking Drill GuideLDG-5010-65 6.5mm Locking Drill GuideDDG-5010-01 5.0mm/3.2 mm Double Drill GuideCDG-5010-01 3.2mm Compression Drill GuidePDG-5010-01 Depth Gauge for Plate ScrewsTSS-5010-01 TX 25 Driver Shaft w/Quick ConnectFS-1006 Ratchet Driver HandlegS 86.1002 AO Trinkle AdaptergS 86.6110 Screw Holding ForcepsCSK-5010-01 Countersink w/AO Quick ConnectPFP-5010-32 Large PF Pin w/AO Quick ConnectGTB-1000-01 Guide Pin Targeting Base, Left (Red)GTB-1000-02 Guide Pin Targeting Base, Right (Green)GTB-1000-03 Targeting Base Knob GTS-1000-01 Guide Pin Targeting SleevegS 52.5520 3/4” Wide Str. Smith Peterson Osteotome

GDW-895-00 2.0mm x 150mm Guide PinDRL-1000-32 3.2mm Long Drill Bit DRL-5010-32 3.2mm Drill BitDRL-5010-50 5.0mm Drill Bit

Description

Description

Lateral TTC Fusion Locking Plate

Anterior Ankle Fusion Locking Plate

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Essential Product Information

Warnings and Precautions

• No metallic surgical implant should be reused. Any metal implant, once used, should be discarded. Even though it appears undamaged, it may already have small defects and internal stress patterns which may lead to fatigue failure.

• Correct handling of implant is extremely important. Avoid contouring metallic implants whenever possible. If necessary, or allowed by design, the device should not be bent sharply, reverse bent, notched or scratched. All of these operations can produce defects in the surface finish and internal stress concentrations, which may become the focal point for eventual failure of the appliance.

• If metal plates or other metallic devices are to be used together with the Ankle Fusion Plates, all such devices should be manufactured from a metal that has a similar composition to avert possibility of galvanic corrosion or other metallic reactions.

• Correct selection of the implant is extremely important. The potential for success in fracture fixation is increased by the selection of the proper size, shape and design of the implants. The patient’s anatomy and indication will determine the size of the Ankle Fusion Plate to be used. The size and shape of the human bones presents limiting restrictions on the size and strength of implants.

• Postoperative care is extremely important. The patient must be warned that noncompliance with postoperative instructions could lead to breakage of the implant requiring revision surgery to remove the device.

• The use of Ankle Fusion Plates provides the surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. The implant are intended as a guide to normal healing and are NOT intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue.Allmetalsurgicalimplantsaresubjecttorepeatedstressinusewhichcanresultinmetalfatigue

• Failure to immobilize a delayed union or nonunion of bone will result in excessive and repeated stresses which are transmitted by the body to any temporary internal fixation device prior to the healing of the fracture. Due to normal metal fatigue, these stresses can cause eventual bending or breakage of the device. Therefore, it is important that immobilization of the fracture site is maintained until firm bony union (confirmed by clinical and roentgenographic examination) is established.

• No partial weight bearing or nonweight bearing device can be expected to withstand the unsupported stresses of full weight bearing. Until firm bone union is achieved, the patient should employ adequate external support and restrict physical activities which would place stress upon the implant or allow movement at the fracture site and delay healing.

• Detailed written instructions on the use and limitations of the device should be given to the patient. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending or breakage of the device are complications which may occur as a result of the weight bearing or muscle activity. An active patient or a debilitated or demented patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation.

• While the surgeon must make the final decision on implant removal, whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished, particularly in younger more active patients.

• TheAnkleFusionPlateSystemhasnotbeenevaluatedforsafetyandcompatibilityintheMRenvironment. TheAnkleFusionPlateSystemhasnotbeentestedforheatingormigrationintheMRenvironment.

Integra®

CONSTRUCT Ankle Fusion Plating System

For more information or to place an order, please contact:Integra n 311 Enterprise Drive, Plainsboro, NJ 08536877-444-1122 USA n 609-936-5400 outside USA n 866-800-7742 fax integralife.com

CONSTRUCT, Integra and the Integra logo are registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2012 Integra LifeSciences Corporation. All rights reserved. Printed in USA. 3k 00002273