Sterile-Packaged Large External Fixator Kits. For treatment of long bone and pelvic fractures that require external fixation.

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1 Sterile-Packaged Large External Fixator Kits. For treatment of long bone and pelvic fractures that require external fixation. Large External Fixator Ankle Frame Kit Large External Fixator Trauma Kit Large External Fixator Pelvic Frame Kit Part of the Large External Fixation System

2 Sterile-Packaged Large External Fixator Kits The sterile-packaged Large External Fixator Kits are available in three configurations, to address the fractures most commonly treated with external fixation. Images outlining the steps for suggested frame assembly are printed on the outer Tyvek lid of each kit, to aid the surgeon and operating room staff A Patient Injury Reference Sheet, featuring anatomical line drawings of the skeletal system, is printed on the inner Tyvek lid Sterile kits are ready for immediate use kits include existing large external fixation components already familiar to surgeons and operating room staff Frames may be supplemented with additional components from the Large External Fixation System, if needed The kits include new instruments to aid in frame construction New instrumentation includes: 11 mm combination wrench that clips onto the carbon fiber rods to travel with the patient and allow frame adjustment after application Hand drill for insertion of 5.0 mm Schanz screws without the need for power MRI Conditions devices have been tested for safety in an MR environment. The MR environment is described as the general environment present in the vicinity of an MR scanner and/or anywhere in the procedure room, including the center of the bore of the MR scanner. Testing was performed to determine displacement force, torque and RF heating induced in devices by the magnetic field of the MR scanner. Testing was performed in compliance with ASTM F2052, ASTM F2213 and ASTM F2182. Induced displacement force was measured in 3.0 T active shielded MR scanners at a maximum spatial gradient of 45 mt/cm. The measured value was found to be lower than the acceptable limit established by ASTM F2052. Induced torque was measured in a 3.0 T active shielded MR scanner, and the measured value was found to be lower than the acceptable limit established by ASTM F2213. Testing for RF heating per ASTM F2182 was performed, and the measured value was found to be lower than the acceptable limit when normalized to an SAR of 2.0 W/kg. Field conditions Limits 1.5 T Scanner 3 T Scanner Field strength (T) SAR value (W/kg) db/dt (T/sec) Note: The above field conditions should be compared with those of the user s MR system in order to determine if the item can safely be brought into the user s MR environment. If placed in the bore of the MR scanner during scanning, External Fixation devices may have the potential to cause artifact in the diagnostic imaging. WARNINGS All components of External Fixation frames must be identified as MR Conditional prior to being placed in or near an MR environment. The manual-surgical instruments supplied with the sterile-packaged large external fixator kits may contain magnetic materials and are, therefore, considered to be MR unsafe, and must not be placed in or near an MR environment. Sterile-Packaged Large External Fixator Kits

3 Indications The Large External Fixation System is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures Polytrauma/ multiple orthopaedic trauma Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures Arthrodeses and osteotomies with soft tissue problems; failures of total joints Neutralization of fractures stabilized with limited internal fixation Nonunions/ septic nonunions Intraoperative reductions/ stabilization tool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening

4 Kit Configurations Large External Fixator Ankle Frame Kit, sterile ( S) Includes standard components to construct a delta frame ankle bridge: Implants mm Steinmann Pin with central 1 thread, 250 mm, mm Self-Drilling Schanz Screw, mm, Large Multi-Pin Clamp, 6 position, Rod Attachment for Large 1 Multi-Pin Clamp, Large Open Adjustable Clamp, mm Carbon Fiber Rod, 300 mm 2 Instruments 11 mm Combination Wrench mm Drill Sleeve mm Drill Bit, quick coupling 1 For additional information, please refer to package inserts. Sterile-Packaged Large External Fixator Kits

5 Large External Fixator Trauma Kit, sterile ( S) Includes standard components to construct a tibial shaft frame: Implants mm Self-Drilling Schanz Screw, mm, Large Combination Clamp, Large Pin Clamp 6-Position, º Outrigger Post, 11 mm, mm Carbon Fiber Rod, 400 mm, 1 Instruments 11 mm Combination Wrench 1 11 mm Hex Nut Driver mm Drill Sleeve 1 Hand Drill 5.0 mm Schanz Screws 1 Safety Scalpel No For additional information, please refer to package inserts.

6 Kit Configurations continued Large External Fixator Pelvic Frame Kit, sterile ( S) Includes standard components to construct a pelvic frame: Implants mm Schanz Screw, 4 blunted trocar point, Large Combination Clamp, Large Open Adjustable Clamp, mm Carbon Fiber Rod, 300 mm, mm Carbon Fiber Rod, 350 mm, 1 Instruments mm Drill Bit, quick coupling 1 11 mm Combination Wrench mm Drill Sleeve 1 For additional information, please refer to package inserts. Sterile-Packaged Large External Fixator Kits

7 (USA) 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) , Inc. or its affiliates. All rights reserved. is a trademark of, Inc. or its affiliates. Printed in U.S.A. 7/09 J9149-A