VariAx TM Distal Radius Locking Plate System

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Andrew Hodge
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1 Osteosynthesis VariAx TM Distal Radius Locking Plate System Operative Technique Anatomical & Universal Volar Plates Dorsal Plates Fragment Specific Plates

Introduction -15 +15 The NEW VariAx Distal Radius Plating System

Anatomical Volar and Dorsal, Universal Volar and Fragment

$fracture.$ pre-determined angle.

angulation of ±15 degrees in any hole on the plate, except the

New Anatomical Volar Plate Encourages articular support with

lunate facet and stable fixation of radial styloid fragments

$intraoperative solutions for different fracture fixation$ requirements.

Radius Locking Plates and reduces the incidence of tissue

SmartLock Locking Technology: Patented SmartLock Locking

combination of Grade II - Ti Plates and Grade V - Ti Screws &

2 Introduction The NEW VariAx Distal Radius Plating System represents the Next Generation of Bone Fixation for your Distal Radius Fracture Needs. System Features: Comprehensive Plating System Providing Anatomical Volar and Dorsal, Universal Volar and Fragment Specific Solutions, even for the most complex distal radius fracture. Fixed Angle Drill Guide Assures placement of screws & pegs in a pre-determined angle. Polyaxial Drill Guide Allows locking with an additional angulation of ±15 degrees in any hole on the plate, except the oblong hole in the shaft. New Anatomical Volar Plate Encourages articular support with Locking screws & pegs, provides optimal buttressing to the volar lunate facet and stable fixation of radial styloid fragments with two screws. Full range of 2.0mm to 2.7mm Locking and Non-Locking screws & pegs Offering intraoperative solutions for different fracture fixation requirements. Anodization Type II Increases the strength of all VariAx Distal Radius Locking Plates and reduces the incidence of tissue adherence. SmartLock Locking Technology: Patented SmartLock Locking Technology Encourages locked screw to plate interface due to combination of Grade II - Ti Plates and Grade V - Ti Screws & Pegs. SmartLock Locking Screws & Pegs Designed with threads on the underside of the screw head, which upon insertion engage the circular lip within any hole on the plate, except the oblong hole in the shaft. Unique one-step Locking Is achieved by simply inserting a Locking Screw or Peg within the polyaxial locking range of ±15 degrees, without the need for further steps. Cross-Pin Screw Head Design Optimal axial stability friction fit Easy screw pick up 2

3 Overview Plate Options Left Right Anatomical Volar Plates Universal Volar Plates Dorsal Plates Radial Column Plates Ulnar Column Plates Screw/Peg Options 2.0mm Smooth Locking 2.3mm Locking 2.7mm Locking 2.7mm Partial Thread Locking 2.3mm Non- Locking 2.7mm Non- Locking 2.7mm Partial Thread Non-Locking 3

Operative Technique Anatomical Volar Plate 1.

If more exposure is necessary, the incision can be extended radially at 45 degrees along the wrist

The FCR tendon is retracted ulnarly and dissection is carried down through the floor of the FCR

The Pronator Quadratus is identified and dissected in its entirety off of the volar surface of the

$Left Right 5. The fracture is visualized and reduced. 6.$ If necessary, bone graft materials may be used as an adjunct to the plate to provide an optimal

If necessary, bone graft materials may be used as an adjunct to the plate to provide an optimal

$The use of AP/Lateral fluoroscopy is helpful to determine correct fracture reduction and plate$ $articular fracture fragments and also to avoid inserting screws or pegs into the joint. 9.$ Zebra striped K-wires and/or Olive K-wires can be used for temporary fixation while evaluating the

Zebra striped K-wires and/or Olive K-wires can be used for temporary fixation while evaluating the

The first pilot hole should be drilled in the oval gliding hole using the appropriate drill guide.

A non-locking screw is placed in the oval gliding hole but not completely tightened to allow

4 Operative Technique Anatomical Volar Plate 1. An incision is made approximately 8cm long just radial to the FCR tendon. If more exposure is necessary, the incision can be extended radially at 45 degrees along the wrist flexion creases. 2. The FCR tendon is retracted ulnarly and dissection is carried down through the floor of the FCR sheath. This exposes the FCR muscle belly, which may be retracted ulnarly as well. 3. The Pronator Quadratus is identified and dissected in its entirety off of the volar surface of the radius as an ulnarly based flap. 4. The insertion of the Brachioradialis may be released. Left Right 5. The fracture is visualized and reduced. 6. The use of external traction, and/or the use of K-wires for temporary fixation may be helpful. If necessary, bone graft materials may be used as an adjunct to the plate to provide an optimal bone void filler. The use of AP/Lateral fluoroscopy is helpful to determine correct fracture reduction and plate position. 7. Choose the appropriate implant according to patient anatomy and fracture pattern. 8. The plate should be placed slightly below the distal edge of the radius to support the volar articular fracture fragments and also to avoid inserting screws or pegs into the joint. 9. Zebra striped K-wires and/or Olive K-wires can be used for temporary fixation while evaluating the placement of the plate. 10. The first pilot hole should be drilled in the oval gliding hole using the appropriate drill guide. 11. Use the depth gauge to determine screw length. 12. A non-locking screw is placed in the oval gliding hole but not completely tightened to allow adjustment of the plate in distal or proximal directions. 13. After confirmation of the correct positioning of the anatomic volar plate by use of fluoroscopy, tighten the first screw. 14. Once the position of the plate has been determined, it is time to decide which drill guide to use based upon preference and/or fracture pattern. 4 Note: Using one of the provided drill guides for screw hole preparation is mandatory. Not using a drill guide may lead to drilling out of specified locking range and severely compromise the locking capabilities.

Operative Technique Fixed Angle Drill Guide This drill guide will ensure the same placement of screw options in every case and

It is designed to fit in the pre-tilted lips within the holes on the plate by simply pressing the drill guide in to the hole.

When utilizing this instrument follow the same trajectory of the pre-tilted lips to facilitate its placement.

$may be used for more complex fractures. A lip on the drill sleeve will engage and allow toggling in the hole.$ The range in which the drill guide toggles will create a 30 degrees cone and every angle in this range will be a locking position.

The range in which the drill guide toggles will create a 30 degrees cone and every angle in this range will be a locking position.

$Also, depending on the placement of the plate, there may be a need to angle a screw/peg out of the fracture line.$ 3mm Drill Guide/K-Wire Guide The K-wire guide provides an option to assess potential screw positions by inserting a 1.

3mm Drill Guide/K-Wire Guide The K-wire guide provides an option to assess potential screw positions by inserting a 1.

By using the same technique, this K-wire guide offers the same 30 degrees locking cone as the SmartLock Polyaxial Drill Guide.

3mm drill guide can be used as an overdrill to lag 2.3mm screws if compression is desired or as a pilot hole for 2.

5 Operative Technique Fixed Angle Drill Guide This drill guide will ensure the same placement of screw options in every case and therefore does not allow the flexibility of choosing an angle. It is designed to fit in the pre-tilted lips within the holes on the plate by simply pressing the drill guide in to the hole. Note: In order to prevent toggling, this drill guide is designed to fit very tightly into the holes of the plate. When utilizing this instrument follow the same trajectory of the pre-tilted lips to facilitate its placement. 18 distal 12 lateral 15 distal 15 lateral 15 distal 15 lateral 0 5 proximal 0 18 distal 12 lateral 12 proximal 5 proximal Pre-determined Screw Pattern 0 10 proximal 5 proximal SmartLock Polyaxial Drill Guide Allows for ±15 degrees of custom angulation and may be used for more complex fractures. A lip on the drill sleeve will engage and allow toggling in the hole. The range in which the drill guide toggles will create a 30 degrees cone and every angle in this range will be a locking position. This may allow for the surgeon to aim where the screw/peg should be placed. Also, depending on the placement of the plate, there may be a need to angle a screw/peg out of the fracture line. Note: First fully engage the drill guide in the hole and then aim the drill in the desired direction. 2.3mm Drill Guide/K-Wire Guide The K-wire guide provides an option to assess potential screw positions by inserting a 1.1mm K-wire prior to any drilling or screw insertion. By using the same technique, this K-wire guide offers the same 30 degrees locking cone as the SmartLock Polyaxial Drill Guide. It may also be utilized to provide temporary fixation to smaller fragments, while catching these with adjacent locking screws. The 2.3mm drill guide can be used as an overdrill to lag 2.3mm screws if compression is desired or as a pilot hole for 2.7mm screws in dense bone. This drill guide can only be used in a fixed angle. 15. Using the desired drill guide, repeat drilling, measuring and placement of screws/ pegs in the distal holes. 16. Place locking or non-locking screws in the proximal end of the plate. Note: In very dense bone it is recommended to use the 2.3mm drill bit in conjunction with the 2.3mm drill guide for a 2.7mm screw. 17. Verify proper placement of screws/pegs by use of fluoroscopy to ensure that neither penetrate the joint. 18. Close the incision. 5

Operative Technique Universal Volar Plate 1.

If more exposure is necessary, the incision can be extended radially at 45 degrees along

The FCR tendon is retracted ulnarly and dissection is carried down through the floor of

3. The Pronater Quadratus is identified and dissected in its entirety off of the volar

$The insertion of the Brachioradialis may be released. 5. The fracture is visualized. 6.$ The use of external traction, and/or the use of K-wires for temporary fixation could be

The use of external traction, and/or the use of K-wires for temporary fixation could be

if necessary, bone graft materials may be used as an adjunct to the plate to provide an

The plate should be placed slightly below the distal edge of the distal radius to avoid

$The use of AP/Lat fluoroscopy is helpful to determine correct fracture reduction and$ The first pilot hole should be drilled in the oval gliding hole using the appropriate

The first pilot hole should be drilled in the oval gliding hole using the appropriate

The screw is placed in the oval gliding hole but not completely tightened to allow

6 Operative Technique Universal Volar Plate 1. An incision is made approximately 8cm long directly over the FCR tendon. If more exposure is necessary, the incision can be extended radially at 45 degrees along the wrist flexion creases. 2. The FCR tendon is retracted ulnarly and dissection is carried down through the floor of the FCR sheath. This exposes the FCR muscle belly, which may be retracted ulnarly as well. 3. The Pronater Quadratus is identified and dissected in its entirety off of the volar surface of the radius as an ulnarly based flap. 4. The insertion of the Brachioradialis may be released. 5. The fracture is visualized. 6. The fracture is reduced. The use of external traction, and/or the use of K-wires for temporary fixation could be helpful.if necessary, bone graft materials may be used as an adjunct to the plate to provide an optimal bone void filler. 7. The plate should be placed slightly below the distal edge of the distal radius to avoid inserting screws or pegs into the joint. The use of AP/Lat fluoroscopy is helpful to determine correct fracture reduction and plate position. 6. K-wires can be used for temporary fixation. 9. The first pilot hole should be drilled in the oval gliding hole using the appropriate drill guide. 10. Measure the depth of the hole to determine screw length. 11. The screw is placed in the oval gliding hole but not completely tightened to allow adjustment of the plate in distal or proximal directions. 12. After confirmation of the correct positioning of the volar plate by use of fluoroscopy, tighten the first screw. 13. Repeat drilling, measuring and placing of screws/pegs in the distal holes of the plate. The position and number of screws applied depends on the type of fracture. 14. Place the bone or locking screws in the proximal end of the plate. 15. Verify proper placement of screws and pegs by use of fluoroscopy to ensure that neither penetrates the joint. 16. Close the incision. 6

The third compartment is opened and the extensor pollicis longus is

The second compartment wrist extensors are subperiosteally elevated

$The fracture is reduced.$ The use of an external traction device and/or K-wires for temporary

If necessary, bone graft materials may be used as an adjunct to the plate

If necessary, adapt the plate for correct anatomical position.

The plate should be placed slightly below the distal edge of the distal

Correct positioning of the plate should be confirmed by use of

The first pilot hole should be drilled in the oval gliding hole. 7.

Check the screw length on the measuring scale of the implant module

The screw is placed in the oval gliding hole but not completely tightened

7 Operative Technique Dorsal Plate 1. Longitudinal incision is made just ulnar to Lister s tubercle at the distal radius region. 2. Dissection is performed down to the extensor retinaculum. The third compartment is opened and the extensor pollicis longus is displaced radially. 3. The second compartment wrist extensors are subperiosteally elevated radially and the fourth compartment is subperiosteally elevated ulnarly. The dorsal interosseous nerve might be cut off for pain reduction. 4. The fracture is reduced. The use of an external traction device and/or K-wires for temporary fixation may be helpful. If necessary, bone graft materials may be used as an adjunct to the plate to provide an optimal bone void filler. 5. If necessary, adapt the plate for correct anatomical position. Removal of tuberculum listeri might be necessary. 6. The plate should be placed slightly below the distal edge of the distal radius to avoid inserting screws/pegs into the joint. Correct positioning of the plate should be confirmed by use of fluoroscopy. The first pilot hole should be drilled in the oval gliding hole. 7. Measure the depth of the hole to determine screw length. 8. Check the screw length on the measuring scale of the implant module (optional). 9. The screw is placed in the oval gliding hole but not completely tightened to allow adjustment of the plate in a distal or proximal direction. 10. Confirm proper plate positioning by use of fluoroscopy and then tighten the first screw. 11. Repeat drilling, measuring, and placing of screws/pegs into the distal holes of the plate. The position and number of screws applied depends on the type of fracture. 12. Place bone or locking screws in the proximal end of the plate. 13. Confirm correct placement by use of fluoroscopy. 14. Verify proper placement of screws and pegs by use of fluoroscopy to ensure that neither penetrates the joint. 15. Close the incision. 7

8 Operative Technique Radial Column Plate 1. Incision is made along the radial column. 2. Care must be taken to avoid injury to dorsal sensory branch of the radial nerve. 3. First dorsal compartment is freed from dorsal to volar to allow plate placement. 4. Plate is placed along the radial column. 5. Screws or distal K-wires can be placed for fixation options. 6. The 3 in 1 K-wire bender/cutter/inserter is used to place K-wires distally. 7. It is recommended only one K-wire be placed distally at a time in order to make proper use of the bender/cutter/inserter instrument. 8. After insertion, the tamp and mallet can be used to further insert the K-wires. 9. K-wires and screws can be placed in conjunction for more rigid fixation. 10. The incision is closed. 8

Ordering Information Volar Plates Dorsal Plates 54-25384

54-25376 Narrow, Left Standard, Right Standard, Left

Narrow, Right, Long 54-25293 Wide, Left 54-25375 54-25387

Standard, Left, Long 54-25294 54-25295 Standard, Right,

54-25296 Wide, Right, XLong 54-25396 Standard, Short

Specific Plates 54-25395 54-25397 Narrow, Long Standard,

Radial Column Plate Long Ulnar Column Plate Short, Right

Left 54-25391 54-25392 Narrow, XLong Standard, XLong

9 Ordering Information Volar Plates Dorsal Plates Narrow, Right Standard, Right Narrow, Left Standard, Right Standard, Left Standard, Left Wide, Right Narrow, Right, Long Wide, Left Narrow, Left, Long Standard, Right, Long Standard, Left, Long Standard, Right, XLong Standard, Left, XLong Narrow, Short Wide, Right, XLong Standard, Short Wide, Left, Xlong Wide, Short Fragment Specific Plates Narrow, Long Standard, Long Radial Column Plate Short Radial Column Plate Long Ulnar Column Plate Short, Right Wide, Long Ulnar Column Plate Short, Left Narrow, XLong Standard, XLong Ulnar Column Plate Long, Right Ulnar Column Plate Long, Left Wide, XLong 9

10 Ordering Information 2.0mm Locking Pegs * 2.7mm Bone Screws * Ti Length mm Ti Length mm mm 18mm 20mm 22mm 24mm 26mm mm 12mm 14mm 16mm 18mm 20mm 22mm 24mm 26mm 2.3mm Locking Screws * 2.3mm Bone Screws * Ti Length mm Ti Length mm mm 12mm 14mm 16mm 18mm 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm mm 12mm 14mm 16mm 18mm 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 2.7mm Locking Screws * 2.7mm Partially Threaded Bone Screws * Ti Length mm Ti Length mm mm 12mm 14mm 16mm 18mm 20mm 22mm 24mm 26mm mm 18mm 20mm 22mm 24mm 26mm 2.7 mm Partially Threaded Locking Pegs * Ti Length mm 16mm 18mm 20mm 22mm 24mm 26mm Twist Drills mm, Stryker shaft end 2.3mm, AO shaft end 2.3mm, Dental shaft end 2.0mm, Stryker shaft end 2.0mm, AO shaft end 2.0mm, Dental shaft end 1.9mm, Stryker shaft end 1.9mm, AO shaft end 1.9mm, Dental shaft end * Order Quantity: Packages of 5 10

Ordering Information Instrumentation Implant Module 62-20290 Screwdriver Ratcheting Handle 29-27001 VariAx Distal Radius Locking Implant

7mm 56-01250 Polyaxial Drill Guide 2.3mm/2.7mm 29-27002 Inlay for Anatomical Volar Distal Radius Plates 56-01255 Fixed Angle Drill Guide 2.

3mm Overdrill and K-Wire Guide 62-00016 Depth Measuring Gauge Sterilizing Container 64-20117 Plate Bending Pliers 29-13012 VariAx Lid for

Lid Bone Reduction Instruments 07-30600 Lobster Bone Holding Forceps 29-13114 VariAx Distal Radius Plating Instrument Tray 07-30111 Lewin Bone

Elevator, Double sided, Strong&Light Curved Optional Items 07-10175 43-09830 64-00011 Bone Hook Mallet (250g) Tamp 62-00017 50-23501 50-27500

0mm K-wires 50-23001 50-27000 50-27001 Marker - Bone Screws 2.3mm Marker - Bone Screws 2.7mm Marker - PT Bone Screws 2.

11 Ordering Information Instrumentation Implant Module Screwdriver Ratcheting Handle VariAx Distal Radius Locking Implant Module, double-sized Cross-Pin Blade 2.3mm/2.7mm Polyaxial Drill Guide 2.3mm/2.7mm Inlay for Anatomical Volar Distal Radius Plates Fixed Angle Drill Guide 2.3mm/2.7mm Inlay for Universal Volar Distal Radius Plates mm Overdrill and K-Wire Guide Depth Measuring Gauge Sterilizing Container Plate Bending Pliers VariAx Lid for Sterilizing Container K-wire Bending Pliers Forceps with Grasping Lips Sterilizing Container, Halfsize, w/o VariAx Lid Bone Reduction Instruments Lobster Bone Holding Forceps VariAx Distal Radius Plating Instrument Tray Lewin Bone Holding Forceps, Sharp Tip VariAx Distal Radius Bone Reduction Tray Elevator, Double sided, Narrow&Wide, Hohmanns Elevator, Double sided, Strong&Light Curved Optional Items Bone Hook Mallet (250g) Tamp Depth Measuring Gauge (Aluminium, UDR Version) Marker - Locking Screws 2.3mm Marker - Locking Screws 2.7mm Marker - Locking Pegs 2.0mm K-wires Marker - Bone Screws 2.3mm Marker - Bone Screws 2.7mm Marker - PT Bone Screws 2.7mm K-wire with Olive Stop * K-wire, 1.1x160mm ** Marker - PT Locking Pegs 2.7mm Marker - 2.3mm Note: Following Drills may be ordered sterile by replacing 60- by 91- in their respective Cat.Nr.: / / / * Order Quantity: Packages of 5, ** Order Quantity: Packages of 10 11

12 Complementary Products Now Stryker Osteosynthesis offers you a wide variety of solutions for the treatment of all your Upper Extremity & Hand Injuries. TwinFix KnifeLight T2 Humeral Nail Hoffmann II Micro Lengthener Profyle Modular Hoffmann II Compact MRI AxSOS Proximal Humeral Plate Asnis III 4.0 Cannulated Screws T2 Proximal Humeral Nail 12

13 Notes 13

Trauma, Extremities & Deformities Biologics Surgical Products Neuro & ENT Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 D-79111 Freiburg Germany www.osteosynthesis.stryker.

14 Trauma, Extremities & Deformities Biologics Surgical Products Neuro & ENT Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 D Freiburg Germany The information presented in this brochure is intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Surgeons must always rely on their own clinical judgment when deciding which products and techniques to use with their patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its subsidiary owns the registered trademark: Stryker Stryker Corporation or its subsidiary owns, uses or has applied for the following trademarks: VariAx Literature Number: LOT B4806 Copyright 2006 Stryker Printed in Germany

VariAx Distal Radius Locking Plate System

Osteosynthesis VariAx Distal Radius Locking Plate System Operative Technique Anatomical & Universal Volar Plates Dorsal Plates Fragment Specific Plates Introduction The VariAx Distal Radius Plating System