T2 Arthrodesis Nailing System

Operative Technique

1 Knee Arthrodesis Nailing System

Contributing Surgeons

Stephen Incavo MD University of Vermont Department of Orthopaedics & Rehabilitation Burlington/Vermont, USA

Prof. Dr. Dr. Gunther O. Hofmann Chief of Surgical Services Medical Director of Halle Trauma Center Halle, Germany Director of Trauma Department Friedrich-Schiller-University Jena, Germany

This publication sets forth detailed recommended procedures for using Stryker Osteosynthesis devices and instruments.

It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required.

A workshop training is required prior to first surgery.

All non-sterile devices must be cleaned and sterilized before use. Follow the instructions provided in our reprocessing guide (L24002000). Multi-component instruments must be disassembled for cleaning. Please refer to the corresponding assembly/ disassembly instructions.

See package insert (L22000007) for a complete list of potential adverse effects, contraindications, warnings and precautions. The surgeon must Reference discuss all relevant risks, including 1. Incavo S., Lily J. ,Churchill the finite lifetime of the device, with Bartlett C., Arthrodesis of the Knee: the patient, when necessary. Experience with Intramedullary Nailing. Journal of Arthroplasty Warning: 15 (7) 871−876, 2000 All bone screws referenced in this document here are not approved 2. Hofmann G.O., Therapeutische for screw attachment or fixation Optionen bei persistierendem to the posterior elements Kniegelenkinfekt, Trauma (pedicles) of the cervical, Berufskrankheit 5 (2003), 221−224 thoracic or lumbar spine. 2 Contents

Page 1. Introduction 4 Implant Features 4 Instrument Features 4 2. Indications, Precautions & Contraindications 5 Indications 5 Precautions 5 Relative Contraindications 5 3. Technical Details 6 System Specifications 6 4. Operative Technique 7 Pre-operative Planning 7 Patient Positioning 7 Knee Incision 7 Hip Incision and Entry Point 7 Reaming 8 Nail Assembly 8 Nail Insertion Preparation 9 Nail Insertion 10 Guided Locking Mode (via Targeting Device) 11 Static Locking 12 Apposition/Compression Locking Mode 14 Freehand Distal Locking 15

Ordering Information – Implants 16 Ordering Information – Instruments 17

3 Introduction

The T2 Nailing System represents In addition to the T2 Femoral, Tibial, Stryker´s latest and most com- and Humeral Nailing Systems, prehensive development of the original Stryker developed the T2 Arthrodesis intra-medullary principles presented Nail to provide treatment of Knee by Prof. Gerhard Küntscher in 1940. Arthrodesis.

Stryker has created a new generation Through the development of a locking nail system, bringing together common, streamlined and intuitive all the capabilities and benefits of surgical approach, both in principle separate nailing systems to create a and in detail, the T2 Arthrodesis Nail single, integrated surgical resource for offers significantly increased speed fixation of long bones. and functionality for the treatment of Knee Arthrodesis as well as simpli- fying the training requirements for all personnel involved.

Implant Features Instrument Features The T2 Arthrodesis Nail is the The T2 Arthrodesis Nail is inserted realization of strong biomechanical with the existing T2 Basic Set, Long intramedullary stabilization using together with the Femur Indication small caliber cannulated implants for Set. internal fixation of long bones. Note: The design of the T2 Arthrodesis The core instruments of the T2 Nail features a unique curvature system provide the platform for which incorporates both femur all current and future Stryker antecurvature and knee valgus bend. Nailing Systems, thereby reducing This design dictates the need for both complexity and inventory. left and right implants providing Refer to the T2 Femoral Nailing an improved fit for each patient’s System Operative Technique individual needs. All T2 Arthrodesis (REF B1000004) and T2 Tibial Nail implants are made of Type II Nailing System Operative anodized titanium alloy (Ti6Al4V) Technique (REF B1000005) for for enhanced biomechanical and more detailed system protocols. biomedical performance. All implants are provided in sterile packaging.

4 Indications, Precautions and Contraindication

Indications Precautions Aseptic failed total knee arthro-plasty The T2 System has not been evaluated with or without bone loss for safety and compatibility in the MR • Failed external fixation, environment. nonunions and malunions The T2 System has not been tested • Periarticular fractures where for heating or migration in the MR repair is not possible environment. • Pathologic fractures, impending pathologic fractures and tumor resections • Pseudoarthrosis and correction osteotomy • Ipsilateral femur fractures • Open and closed femoral fractures

Relative Contraindications The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include: • Any active or suspected latent • Implant utilization that would infection or marked local interfere with anatomical inflammation in or about the structures or physiological affected area. performance. • Compromised vascularity that • Any mental or neuromuscular would inhibit adequate blood disorder which would create an supply to the fracture or the unacceptable risk of fixation operative site. failure or complications in • Bone stock compromised by postoperative care. disease, infection or prior implan- • Other medical or surgical tation that can not provide conditions which would preclude adequate support and/or fixation the potential benefit of surgery. of the devices. • Material sensitivity, documented or suspected. • Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself. • Patients having inadequate tissue coverage over the operative site.

5 Technical Details

System Specifications Two Nails, Left and Right 0mm Diameters: 11.5 & 13mm Lengths: 540 − 780mm in 40mm increments 32.5mm 35mm Compression Range: 45mm Total Length of Slot 15mm 47.5mm Less Screw Diameter (−) 5mm 60mm

Maximum Movement of Screw 10mm

Screws, End caps & Compression Screw

(See Page 16 for complete description and catalog numbers)

75 mm

35 mm 25 mm

0 mm

6 Operative Technique

Pre-operative Hip Incision and Entry Point Planning A skin incision is made beginning at the level of the Greater Trochanter Noting any deformity of the axis An X-Ray Template (1806-0011) is extending proximal and slightly of the tibial shaft, and using either available for pre-operative planning. posterior, in line with the Gluteus the Awl or Rigid Reamer over the Implant sizing is best determined Muscle, exposing the Piriformis K-Wire, open the anterior central using full length A/P and Lateral Fossa. Alternatively, the Tip of the medial aspect of the tibia using the X-Rays of both the affected and Greater Trochanter can be located tibial tubercle as a reference to the contralateral legs. C.T. Scan for canal by palpation, and a horizontal skin medullary canal. diameter and leg length may be useful. incision is made from the Greater The knee should be placed in 5−10˚ of Trochanter to the Iliac Crest. The Insert the 1250mm Ball Tip Guide flexion and 5˚ valgus. The leg should medullary canal is opened with the Wire (1806-1250S) from the hip be 1cm shorter than the opposite curved awl (1806-0040), or with a through the knee and advance into the side. This position allows for more 3×285mm K-Wire (1806-0050) and tibial shaft to the depth at which you normal gait and foot clearance during Ø12mm Rigid Reamer (1806-2014) want the nail to end. walking. combination. Ultimately, 1 cm of leg shortening The Guide Wire Ruler (1806-0022) is the goal, therefore in cases with Alternatively, a minimal skin incision features dedicated marks to identify more significant bone loss, additional of the hip region can be made if the the to be choosen nail length when flexion should be avoided to minimize femoral canal is reamed in retrograde using the 1250mm Guide Wire. additional shortening. fashion from the knee joint. To accomplish this, the 3×1250mm Caution: Ball Tip Guide Wire (1806-1250S) Use image intensification (A/P is advanced from the distal femoral and Lateral) for confirmation Nail Length canal proximally to the greater throughout each step. The nail length is surgeon dependent trochanteric / piriformis fossa region. with regards to the individual situation of the patient and with Warning: regards on how long the nail should Avoid the femoral neck. The extend into the Tibia. Guide Wire is then gently advanced through the cortex by gently tapping the strike plate on the Guide Wire Handle/ Chuck assembly. Fluoroscopic visualization is necessary for this Patient Positioning step. Once the Guide Wire exits the bone, it is retrieved through a Patient positioning is surgeon small skin incision made over the dependent. The patient may be tip of the Guide Wire. positioned supine (elevate the affected hip), lateral or semi-lateral on a radiolucent table. Use image intensification (A/P and Lateral) for confirmation throughout each step. Knee Incision A vertical skin incision is made extending from the femoral condylar region to the tibial tubercule, followed by a parapatellar capsular incision. In cases with a previous incision, this one could be used. Knee arthroplasty instruments may be used to recut tibial and femoral surfaces.

7 Operative Technique

Reaming Nailing Holding Screw Using a 885mm Bixcut Modular Reamer Shaft (REF Numbers on page 16), reaming is commenced in Strike Plate 0.5mm increments. Generally, the femur is reamed 1.5 – 2.0mm larger than the diameter of the nail selected, and the tibia is reamed line to line. Fixation Screw The proximal end of the tibial shaft Clamp may be over-reamed if there is any question of final Femoral-Tibial alignment. Final determination of how Fixation Screw much to ream either the femur or the tibia must be made by the surgeon based on many factors including Nail Handle bone quality and whether the nail will be cross-locked with screws distally in the tibia. As stated above, in some cases, surgeons may opt to use standard length Guide Wires and Reamers and ream the femur in retrograde fashion first and then the tibia separately. K-Wire Hole Nail Assembly

The selected nail is assembled onto the Targeting Arm Target Device (1806-1005) with the Femoral Holding Screw (1806-0165) (Fig. 1). Tighten the Nail Holding Screw with the Universal Socket Wrench (1806-0400) securely so that it does not loosen during nail insertion.

Alternatively, the Fixation Screw Clamp (1806-0273) can be used to fix the Targeting Arm to the Nail Handle. After clamping it on the Targeting Arm the knob will tighten the sleeve to the Targeting Arm.

Caution: Curvature of the nail must match the curvature of the femur and knee valgus.

Fig. 1

8 Operative Technique

Nail Insertion Preparation Upon completion of reaming, the appropriate size nail is ready for insertion over the 3×1250mm Ball Tip Guide Wire (1806-1250S). The Slotted Hammer can be used on the Strike Plate, or if dense bone is encountered, the Universal Rod (1806-0110) may be attached to the Nail Holding Screw and used in con- junction with the Slotted Hammer to insert the nail (Fig. 2).

Caution: Prior to insertion, check for correct assembly into the nail Fig. 2 by passing a drill Bit through the Target Device and through the nail holes to help check alignment. 2 mm DO NOT hit on the Targeting Device.

When locking the nail in the Static 5 mm Static Mode, the nail is countersunk a 10 mm Dynamic minimum of 5mm (Fig. 4). When the 15 mm Apposition/Compression implant is inserted in the dynamic mode, without active apposition/ compression, or when the implant Fig. 3 is inserted with active apposition/ compression, the recommended depth of insertion is 15mm (Fig. 5).

Caution: • The system offers the option of different locking modes. In addition to static locking, a controlled dynamization or a controlled apposition/ compression can be mechanically applied with an optional internal compression screw. • In cases where the compression Fig. 4 feature is used, the tibia must be locked with cross-locking screws before the compression is applied proximally. Up to 10mm of mechanical compression can be applied. • Additionally, the 3×285mm K-Wire may be inserted through the Target Device which indicates the junction of the nail and insertion post (see Fig. 1).

Fig. 5

9 Operative Technique

Nail Insertion To start the insertion of the nail, it is recommended that the Target Device is internally rotated to accommodate the individual patient’s anatomy (see Fig. 6, Position 1 for appro- ximated example).

As the nail is passed down the femur towards the knee, a controlled external rotation of the Target Device is applied to better accommodate the unique Position 1 dual curvature of the nail passing through the medullary canal (Fig. 7 position 2, 3, 4). Fig. 6

Caution: The amount of internal rotation, and the timing of the external rotation is based on the individual patient’s anatomy and as such, the surgeon’s judgement. The final position of the Target Device must be directly lateral to the femur. In this final position, the hole pattern of the nail is properly lined up for screw insertion. Since every Arthrodesis case is different, the choice of whether to dynamize, actively compress, or statically lock the nail is up to the Position 4 Position 3 Position 2 Position 1 surgeon based on the individual patient’s indications. Fig. 7

Check the alignment of the leg in all axis with proper full length X-Rays and throughout the surgery (Fig. 8).

Caution: As the nail is beginning to be introduced into the tibia, the final position of the foot must be determined with the foot being held in place accordingly as the nail is impacted to its final Fig. 8 position. The amount of external rotation of the foot, generally 0 − 10˚, is left to the surgeon’s discretion.

10 Operative Technique

Guided Locking Mode (via Target Device) In controlled Dynamic Mode, and/or controlled Apposition/Compression Mode, the dynamic hole is required (Fig. 9). 4. Dynamic

In Advanced Locking Mode, the dynamic hole is required. After utilizing compression with the Compression Screw, the distal static hole is used. (Fig. 10). 4 3. Static 4. Dynamic

In Static Locking Mode, the distal Fig. 9 static hole and the static position of the oblong hole are required (Fig. 10). 2. Static 3. Static

Caution: Never use the most proximal static hole of the Target Device! There is no corresponding hole in the Arthrodesis Nail.

The Long Tissue Protection Sleeve (1806-0185) together with the Long 3 2 4 Drill Sleeve (1806-0215) and the Long Trocar (1806-0315) is inserted into the Target Device by pressing the safety clip (Fig. 11). The mechanism will Fig. 10 keep the sleeve in place and prevent it from falling out. It will also prevent the sleeve from sliding during screw measurement. To release the Tissue Protection Sleeve, the safety clip must be pressed again.

Note: Remove the Guide Wire prior to drilling and inserting the Locking Screws.

locked released

Fig. 11

11 Operative Technique

Static Locking Mode The Long Tissue Protection Sleeve together with the Long Drill Sleeve and Long Trocar, are positioned through the most distal static locking hole on the Target Device. A small skin incision is made, and the assembly is pushed through until it is in contact with the lateral cortex of the femur (Fig. 12).

Alternatively, the Trocar (1806-0311) can be advanced together with the Tissue Protection Sleeve. Push the Fig. 12 assembly down to the bone. The paddle tip design may help to pass the soft tissue and prepare the way for drilling. Remove the the Trocar to insert the Drill Sleeve.

Caution: Make sure the Tissue Protection Sleeve/Drill Sleeve Assembly is seated on bone prior to selecting final screw length.

Fig. 13

50mm

The Trocar is removed, with the Tissue Protection Sleeve and the Drill Sleeve remaining in position. To help ensure accurate drilling and easy determination of screw length, use the center tipped, calibrated Ø4.2×340mm Drill (1806-4260S). The centered Drill is forwarded through the Drill Sleeve and pushed onto the cortex.

12 Operative Technique

After drilling both cortices, the screw length may be read directly off of the calibrated Drill at the end of the Drill Sleeve (Fig. 13).

When the Drill Sleeve is removed, the correct Locking Screw is inserted through the Tissue Protection Sleeve using the Long Screwdriver Shaft (1806-0227) with Teardrop Handle (702429) (Fig. 14).

Caution: Fig. 14 The coupling of Elastosil handles contains a mechanism with one or multiple ball bearings. In case of applied axial stress on the Elastosil handle, those components are pressed into the surrounding cylinder resulting in a complete blockage of the device and possible bending. To avoid intra-operative complications and secure long-term functionality, we mandate that Elastosil handles be used only for their intended use. DO NOT HIT any Elastosil Fig. 15 handles.

The screw is advanced through both cortices. The screw is near its proper seating position when the groove around the shaft of the screwdriver is approaching the end of the Tissue Protection Sleeve. Repeat the locking procedure for the other statically positioned Locking Screw (Fig. 15)

13 Operative Technique

Apposition/Compression Locking Mode Note: Distal freehand static locking with at least two Fully Threaded Locking Screws must be performed prior to applying active, controlled apposition/ compression to the fusion site.

If active apposition/compression is required, a Partially Threaded Locking Screw (Shaft Screw) is inserted via the Target Device in the dynamic position of the oblong hole. This will allow for a maximum of 10mm of active, controlled apposition/compression. In order to insert the Shaft Screw, drill Fig. 16 both cortices with the Ø4.2×340mm Drill (1806-4260S). Next, drill the near cortex, ONLY, with the Ø5.0×230mm Drill (1806-5000S).

After the opposite cortex is drilled with the Ø4.2×340mm Drill, the correct screw length can be read directly off of the calibrated Drill at the end of the Drill Sleeve.

After the Shaft Screw is inserted, the Nail Holding Screw securing the nail to the insertion post is removed, leaving the insertion post intact with the nail (Fig. 16). This will act as a guide for the Compression Screw. The Fig. 17 Compression Screw is inserted with the Screwdriver Shaft (1806-0227) assembled on the Teardrop Handle through the insertion post (Fig. 17 & 18).

As the Compression Screw is advanced against the 5mm Partially Threaded Screw (Shaft Screw), active apposition/ compression is applied at the knee site.

Caution: • Apposition/compression should be carried out under X-Ray control. • An End Cap can not be inserted if a Compression Screw has been used. Fig. 18 For optional apposition/compression using the external compression device, please refer to the T2 Femur Operative Technique (B1000004).

14 Operative Technique

Freehand Distal Locking The freehand technique is used to insert Locking Screws into the M/L holes in the nail. Rotational alignment must be checked prior to locking the nail statically. Multiple locking techniques and radiolucent drill devices are available for freehand locking. The critical step with any freehand locking technique is to visualize a perfectly round locking hole with the C-Arm.

The center-tipped Ø4.2×230mm Drill (1806-4290S) is held at an oblique angle to the center of the locking hole (Fig. 19). Upon X-Ray verification, the Drill is placed perpendicular to the Fig. 19 nail and drilled through the medial cortex. Confirm in both the A/P and M/L planes by X-Ray that the Drill passes through the hole in the nail.

After drilling both cortices the screw length may be read directly off of the calibrated Screw Scale, Long (1806- 0365) at the green ring on the center- tipped Drill.

Alternatively, the Screw Gauge can be used to determine the screw length.

Note: The position of the end of the drill is equal to the end of the screw as they relate to the far cortex.

Routine Locking Screw insertion is employed with the assembled Screwdriver Shaft and Teardrop Handle.

15 Ordering Information − Implants

T2 Arthrodesis Nail, left T2 Arthrodesis Nail, right

REF Diameter Length REF Diameter Length mm mm mm mm

1829-1104S 11.5 540 1829-1154S 11.5 540 1829-1108S 11.5 580 1829-1158S 11.5 580 1829-1112S 11.5 620 1829-1162S 11.5 620 1829-1116S 11.5 640 1829-1166S 11.5 640 1829-1120S 11.5 700 1829-1170S 11.5 700 1829-1124S 11.5 740 1829-1174S 11.5 740 1829-1128S 11.5 780 1829-1178S 11.5 780 1829-1304S 13.0 540 1829-1354S 13.0 540 1829-1308S 13.0 580 1829-1358S 13.0 580 1829-1312S 13.0 620 1829-1362S 13.0 620 1829-1316S 13.0 640 1829-1366S 13.0 640 1829-1320S 13.0 700 1829-1370S 13.0 700 1829-1324S 13.0 740 1829-1374S 13.0 740 1829-1328S 13.0 780 1829-1378S 13.0 780

Partially Threaded Locking Screw Fully Threaded Locking Screw

REF Diameter Length REF Diameter Length mm mm mm mm

1891-5025S 5.0 25 1896-5025S 5.0 25 1891-5030S 5.0 30 1896-5030S 5.0 30 1891-5035S 5.0 35 1896-5035S 5.0 35 1891-5040S 5.0 40 1896-5040S 5.0 40 1891-5045S 5.0 45 1896-5045S 5.0 45 1891-5050S 5.0 50 1896-5050S 5.0 50 1891-5055S 5.0 55 1896-5055S 5.0 55 1891-5060S 5.0 60 1896-5060S 5.0 60 1891-5065S 5.0 65 1896-5065S 5.0 65 1891-5070S 5.0 70 1896-5070S 5.0 70 1891-5075S 5.0 75 1896-5075S 5.0 75 1891-5080S 5.0 80 1896-5080S 5.0 80 1891-5085S 5.0 85 1896-5085S 5.0 85 1891-5090S 5.0 90 1896-5090S 5.0 90 1891-5095S 5.0 95 1896-5095S 5.0 95 1891-5100S 5.0 100 1896-5100S 5.0 100 1891-5105S 5.0 105 1896-5105S 5.0 105 1891-5110S 5.0 110 1896-5110S 5.0 110 1891-5115S 5.0 115 1896-5115S 5.0 115 1891-5120S 5.0 120 1896-5120S 5.0 120

End Caps Compression Screw

REF Diameter Length REF Diameter mm mm mm Standard +5mm 1822-0003S 8.0 Standard 1825-0000S 8.0 1822-0005S 11.5 + 5mm 1822-0010S 11.5 +10mm 1822-0015S 11.5 +15mm +10mm +15mm 1822-0020S 11.5 +20mm 1822-0025S 11.5 +25mm 1822-0030S 11.5 +30mm 1822-0035S 11.5 +35mm

+20mm +25mm

+30mm +35mm Note: Federal law (U.S.A) restricts this device to sale by or on the order of a licensed physician. 16 Ordering Information − Instruments

REF Description REF Description Quantity

T2 Basic Long T2 Femur

702429 Teardrop Handle, AO 702427 T-Handle, AO Coupling Coupling 0152-0218* K-Wire 1,8x310mm 2 703165 Protection Sleeve, Retrograde 1806-0015 X-Ray Ruler, Femur

1806-0022 Guide Wire Ruler 1806-0050 K-Wire 3x285mm 2

1806-0065 8mm Hex Screwdriver bit, ball tip

1806-0032 Awl Plug 1806-0165 Nail Holding Screw, 2 Femur 1806-0041 Awl 1806-0255 Screwdriver, Condyle 2 1806-0110 Universal Rod Screw

1806-0125 Reduction Spoon 1806-0257 Revision Screwdriver Bit

1806-0130 Wrench 8mm/10mm 1806-0272 External Compression Device 1806-0135 Insertion Wrench, 10mm 1806-0273 Fixation Screw Clamp

1806-0150 Strike Plate 1806-0311 Trocar, Paddel

1806-0170 Slotted Hammer 1806-0400 Socket Wrench, Universal Joint 10mm 1806-0185 Tissue Protection Sleeve, Long 1806-1005 Target Device, Femur (2 components) 1806-0203 Screwdriver, Self-Holding, Extra Short (3.5)

1806-0215 Drill Sleeve, Long 1806-2016 Countersink for Condyle Screws 1806-0227 Screwdriver Shaft AO, Long 1806-4260* Drill Ø4.2x340, AO

1806-0233 Screwdriver, Self-Holding, 1806-4270* Drill Ø4.2x180, AO Long (3.5) 1806-4290* Drill Ø4.2x230, AO 1806-0268 Screwdriver Shaft, Compression (hex3.5) 1806-5000* Drill Ø5.0x230, AO

1806-0271 Guide Wire Pusher 1806-5020* Drill Ø5.0x340, AO

1806-0315 Trocar, Long 1806-9920 T2 Femur Instrument Tray

1806-0325 Screw Gauge, Long

1806-0331 Screw Gauge (20-120mm)

1806-0350 Extraction Rod, Conical (Ø8mm) Optional Instruments 1806-0365 Screw Scale, Long 1806-0011 X-Ray Template 1806-1095 Guide Wire Handle 1806-1250S Guide Wire, 1250mm 1806-1096 Guide Wire Handle Chuck

1806-2014 Rigid Reamer Ø12mm

1806-9900 T2 Basic Long Instrument Tray

* Instruments designated “Outside of the U. S.” may not be ordered for the U. S. market. 17 Ordering Information – Instruments

Complete range of modular and Bixcut fixed-head reamers to match surgeon preference and optimize O. R. efficiency, presented in fully sterilizable cases.

Large clearance rate resulting from reduced number of reamer blades coupled with reduced length of reamer head to give effective relief of pressure and efficient removal of material.

Cutting flute geometry optimized to lower pressure generation.

Forward- and side-cutting face combination produces efficient material removal and rapid clearance.

Double-wound shaft transmits torque effectively and with high reliability. Low-friction surface finish aids rapid debris clearance.

Smaller, 6 and 8mm shaft diameters significantly reduce IM pressure. Typical Standard Bixcut Reamer Ø14mm Reamer Ø14mm

Studies1 have demonstrated that the pressures developed within the medullary cavity through the introduction of unreamed IMnails can be far greater than those developed Clearance area : Clearance area : during reaming − but this depends 32% of cross section 59% of cross section very much upon the design of the reamer.

After a three year development study2 involving several universities, the factors that determine the pressures and temperatures developed during reaming were clearly established. These factors were applied to the development of advanced reamers that demonstrate significantly better performance than the best of previous designs.

1 Jan Paul M. Frolke, et al. ; Intramedullary Pressure in Reamed Femoral Bixcut Nailing with Two Different Reamer Designs., Eur. J. of Trauma, 2001 #5

2 Medhi Massau, et al.; Pressure Changes During Reaming with Different Parameters and Reamer Designs, Clinical Orthopaedics and Related Research Number 373, pp. 295-303, 2000

18 Ordering Information – Instruments

Bixcut Modular Head Bixcut Fixed Head − AO Fitting**

REF Description Diameter REF Diameter Length mm mm mm

0226-3090 Bixcut Head 9.0 0225-5060 6.0* 400 0226-3095 Bixcut Head 9.5 0225-5065 6.5* 400 0226-3100 Bixcut Head 10.0 0225-5070 7.0* 400 0226-3105 Bixcut Head 10.5 0225-6075 7.5 480 0226-3110 Bixcut Head 11.0 0225-6080 8.0 480 0226-3115 Bixcut Head 11.5 0225-6085 8.5 480 0226-3120 Bixcut Head 12.0 0225-6090 9.0 480 0226-3125 Bixcut Head 12.5 0225-6095 9.5 480 0226-3130 Bixcut Head 13.0 0225-6100 10.0 480 0226-3135 Bixcut Head 13.5 0225-6105 10.5 480 0226-3140 Bixcut Head 14.0 0225-6110 11.0 480 0226-3145 Bixcut Head 14.5 0225-8115 11.5 480 0226-3150 Bixcut Head 15.0 0225-8120 12.0 480 0226-3155 Bixcut Head 15.5 0225-8125 12.5 480 0226-3160 Bixcut Head 16.0 0225-8130 13.0 480 0226-3165 Bixcut Head 16.5 0225-8135 13.5 480 0226-3170 Bixcut Head 17.0 0225-8140 14.0 480 0226-3175 Bixcut Head 17.5 0225-8145 14.5 480 0226-3180 Bixcut Head 18.0 0225-8150 15.0 480 0226-4185 Bixcut Head 18.5 0225-8155 15.5 480 0226-4190 Bixcut Head 19.0 0225-8160 16.0 480 0226-4195 Bixcut Head 19.5 0225-8165 16.5 480 0226-4200 Bixcut Head 20.0 0225-8170 17.0 480 0226-4205 Bixcut Head 20.5 0225-8175 17.5 480 0226-4210 Bixcut Head 21.0 0225-8180 18.0 480 0226-4215 Bixcut Head 21.5 0226-4220 Bixcut Head 22.0 0226-4225 Bixcut Head 22.5 Optional Instruments 0226-4230 Bixcut Head 23.0 0226-4235 Bixcut Head 23.5 REF Description 0226-4240 Bixcut Head 24.0 0226-4245 Bixcut Head 24.5 5235-6-606 Hand Reamer 6 mm w/T-Handle 0226-4250 Bixcut Head 25.0 5235-6-607 Hand Reamer 7 mm w/T-Handle 0226-4255 Bixcut Head 25.5 5235-6-608 Hand Reamer 8 mm w/T-Handle 0226-4260 Bixcut Head 26.0 5235-6-609 Hand Reamer 9 mm w/T-Handle 0226-4265 Bixcut Head 26.5 0227-0060 Hand Reamer 6 mm 0226-4270 Bixcut Head 27.0 w/Mod Trinkle connection 0226-4275 Bixcut Head 27.5 0227-0070 Hand Reamer 7 mm 0226-4280 Bixcut Head 28.0 w/Mod Trinkle connection 0227-0080 Hand Reamer 8 mm

1,2,3, 4 w/Mod Trinkle connection Bixcut Shafts (Sterile) 0227-0090 Hand Reamer 9 mm w/Mod Trinkle connection REF Description Length 1806-6520 Curved Reduction Rod 8.5 mm mm w/Mod Trinkle connection 1806-6500 T-Handle w/Mod Trinkle connection 0227-8240S Mod. Trinkle 284 0227-3000S Mod. Trinkle 448 0227-8510S Mod. Trinkle 510 Bixcut Trays empty 0227-8885S Mod. Trinkle 885 REF Description 0226-8240S AO 284 0226-3000S AO 448 0225-6000 Tray, Modular Head (up to size 22.0mm) Shaft Accessories 0225-6001 Tray, Modular Head (up to size 28.0mm) 0225-8000 Tray, Fixed Head REF Description (up to size 18.0mm) 3212-0-210 Grommet (pack of 25) 0225-6040 Mini Trauma Tray 3212-0-220 Grommet inserter/extractor (for modular heads 9-18) 0225-6010 Grommet Case 0225-6050 Mini Revision Tray (for modular heads 9-28) Note: Bixcut Fixed Head − Modified Trinkle fitting available in same diameters and length as the AO Fitting (REF No: 1227-xxxx) * Use with 2.2mm × 800mm Smooth Tip and 2.5mm × 800mm Ball Tip Guide Wires only. ** Use with Stryker Power Equipment. 1. Non-Sterile shafts supplied without grommet. Use new grommet for each surgery. See Shaft Accessories. 2. Sterile shafts supplied with grommet pre-assembled. 3. For Non-Sterile leave “S” off the REF Number when ordering (510 and 885mm available only sterile Modified Trinkle Fitting). 4. Non-Sterile, AO Fitting Shafts in 510 and 885mm are available as build to order items: • CM810921 AO Fitting Shaft, length 510mm • CM810923 AO Fitting Shaft, length 885mm.

19 Stryker Trauma GmbH Prof.-Küntscher-Straße 1-5 D-24232 Schönkirchen Germany

www.osteosynthesis.stryker.com

This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. 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 including the instructions for Cleaning and Sterilization (if applicable) before using any Stryker products. 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.

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Literature Number : B1000010 LOT F0710