Modular Sternal Cable System. Flexibility and strength in sternal closure and repair. Multiple closure options Stable fixation in all configurations Improved strength and flexibility compared to wire
Modular Sternal Cable System Modular Sternal Closure Options Flexibility in sternal closure due to modular options Intraoperative choice depending on patient s needs Stable fixation in all configurations Sternal cable with an improved strength and stability compared to wire* Sternal cannulated screws for reinforcement of sternal bone quality Sternal reconstruction plates for repair of transverse fractures Peristernal using cable with needle Transsternal using cable and cannulated screws Sternal reconstruction using cable, cannulated screws and plates * See page 4 for mechanical testing results Synthes CMF Modular Sternal Cable System
1.0 mm Sternal Cable Multifilament structure provides improved strength and flexibility A greater bone-to-implant contact area than wire provides a reduced risk for cutting through the sternal bone 7 x 19 filaments Cross sectional view, 1.0 mm diameter cable Flexible cable contours to the shape of the sternum Ferrule is crimped onto the end of the cable to secure the finished construct and avoid sharp edges Available with or without a quick- release needle Ferrule Parallel end fitting Cable Cable with needle Synthes CMF 1
Modular Sternal Cable System continued 4.5 mm Sternal Cannulated Screws Easily insert into the manubrium or sternal body using the adjustable screwdriver blade with spade point Eliminate the need to insert a needle through the sternum Cannulation provides a metal surface for cable to pass through for reinforcement in weak cancellous bone Blunt tip allows safe bicortical insertion Available in lengths from 8 mm to 28 mm, in 1 mm increments 4.5 mm Sternal Reconstruction Plates For reconstruction of sternal transverse fractures Distribute forces along the length of the sternum, reducing the likelihood of bony failure Attach to the sternum with cannulated screws Contourable, to closely match the sternum With transverse holes for peristernal cable passage Available in several lengths (80 mm 192 mm) to minimize intraoperative plate cutting 2 Synthes CMF Modular Sternal Cable System
Tensioner/Crimper/Cutter Single, multipurpose instrumentation Force limiting for easy handling and consistent tensioning 1 Tensioning wheel with force limiting 2 Trigger to crimp and cut the cable 3 Instrument nose for ferrule insertion Tensioning of the cable Crimping the ferrule and cutting the cable with single action Indications Sternal repair and reconstruction Synthes CMF 3
Stable Fixation Implant construct testing Peak load in poor quality bone until cut-through 1 The Modular Sternal Cable System provides increased resistance to implant cut-through in the sternum. Peak Force (N) 300 250 200 214 150 100 260 +21% 279 +30% 50 0 SST Wire Synthes Sternal Cable Synthes Sternal Cable and Cannulated Screws Tensile load at failure of the implants 2 Force (N) 1200 The Modular Sternal Cable System provides greater strength. 1000 800 1028 +187% 1053 +194% 600 400 200 358 0 SST Wire Synthes Sternal Cable Synthes Sternal Cable and Cannulated Screws Fatigue load 3 Maximum load to reach 800,000 cycles** The Modular Sternal Cable System shows a higher resistance to fatigue. Peak Force (N) 300 250 200 150 251 251 100 1. Synthes Mechanical Test Numbers: MT03-005, MT03-006 and MT03-007. All tests were performed on composite polyurethane foam test blocks each measuring 165 mm in length x 40 mm in width x 10 mm thick. The test blocks were composed of an inner (cancellous) core of 5 lb/ft 3 polyurethane foam with a 1.25 mm thick (cortical) shell of 10 lb/ft 3 polyurethane foam laminated to the exterior. All samples were loaded at a rate of 10 mm/minute. 2. Synthes Mechanical Test Number MT04-455. All samples were loaded at a rate of 10 mm/minute. 3. Synthes Mechanical Test Numbers: SET_20060413 and SET_20060213. ** Estimating 20 breaths per minute 24 hours a day, 800,000 cycles would be the equivalent of about 4 weeks. 50 0 25 SST Wire Synthes Sternal Cable Synthes Sternal Cable and Cannulated Screws 4 Synthes CMF Modular Sternal Cable System
Modular Sternal Cable System Sternal Cable Instrument Set (01.501.602) Graphic Case 690.695 Graphic Case, for Modular Sternal Cable System Cable Instrument Set Instruments 391.291 Tensioner/Crimper/Cutter, for 1.0 mm Sternal Cable, 2 ea. 391.905 Cable Cutter, standard 398.903 Sternal Reduction Forceps, angled with teeth, 2 ea. 398.985 Bone Reduction Forceps, large, 2 ea. Implants 291.906 1.0 mm Sternal Crimping Ferrule, long, 1 pkg. of 5 291.907 1.0 mm Sternal Parallel End Fitting, 1 pkg. of 5 Also Available 1.0 mm Sternal Cables, with long crimping ferrule and parallel end fitting, sterile 291.911.01S (without needle), 1 per pkg. 291.911.03S (without needle), 3 per pkg. 291.916.01S with needle, 1 per pkg. 291.916.03S with needle, 3 per pkg. 398.902 Sternal Reduction Forceps Synthes CMF 5
Modular Sternal Cable System 4.5 mm Cannulated Screw and Plate Set (01.501.610) Graphic Cases, Modules and Screw Length Markers 690.696 Modular Sternal Cable System, 4.5 mm Cannulated Screw and Plate Set Graphic Case 305.696 Screw Module, for 4.5 mm Sternal Cannulated Screws 305.697 Plate Module, for 4.5 mm Sternal Reconstruction Plates 304.108 Screw Length Markers, 8 mm 26 mm, 304.126 (10/pkg.), 1 pkg. of each Instruments 03.501.001 Depth Gauge, for 4.5 mm Sternal Cannulated Screws 311.006 Screwdriver Handle with hex coupling, medium, 2 ea. 329.142 Combination Bending Pliers, for 2.0 mm/2.4 mm plates 329.40.98 Bending Template, 37 holes, for reconstruction plates, 2 ea. 351.026 2.7 mm Awl, hex coupling 351.027 Obturator, for Sternal Cable Passer, 37 mm 351.028 Cable Passer, for 1.0 mm Sternal Cable 351.034 4.5 mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea. Implants 4.5 mm Sternal Cannulated Screws 213.508 10 ea.: 8 mm, 9 mm, 25 mm and 26 mm 213.526 15 ea.: 10 mm 24 mm 4.5 mm Sternal Reconstruction Plates, 4 ea. 260.060 10 holes, 80 mm 260.062 12 holes, 96 mm 260.064 14 holes, 112 mm 260.066 16 holes, 128 mm 260.068 18 holes, 144 mm 260.070 20 holes, 160 mm 260.072 22 holes, 176 mm 260.074 24 holes, 192 mm 305.696 305.697 6 Synthes CMF Modular Sternal Cable System
Modular Sternal Cable System 4.5 mm Cannulated Screw Set (01.501.601) Graphic Cases, Modules and Screw Length Markers 690.683 Modular Sternal Cable System Cannulated Screw Set Graphic Case 305.696 Screw Module, for 4.5 mm Sternal Cannulated Screws 304.108 Screw Length Markers, 8 mm 26 mm, 304.126 (10/pkg.), 1 pkg. of each Instruments 03.501.001 Depth Gauge, for 4.5 mm Sternal Cannulated Screws 311.006 Screwdriver Handle with hex coupling, medium, 2 ea. 351.026 2.7 mm Awl, hex coupling 351.027 Obturator, for Sternal Cable Passer, 37 mm 351.028 Cable Passer, for 1.0 mm Sternal Cable 351.034 4.5 mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea. Implants 4.5 mm Sternal Cannulated Screws 213.508 10 ea.: 8 mm, 9 mm, 25 mm and 26 mm 213.526 15 ea.: 10 mm 24 mm 351.034 Also Available 213.525 4.5 mm Sternal Cannulated Screws, 213.528 25 mm 28 mm 304.125 Screw Length Markers, 304.128 25 mm 28 mm 351.035 Replacement Blade, for 4.5 mm Hexagonal Adjustable Screwdriver (351.034) 351.035 Synthes CMF 7
Modular Sternal Cable System Compact 4.5 mm Cannulated Screw and Plate Set (01.501.611) Graphic Case, Module and Screw Length Markers 690.688 Graphic Case for Compact 4.5 mm Cannulated Screw and Plate Set 305.698 Compact 4.5 mm Cannulated Screw and Plate Module 304.108 Screw Length Markers, 8 mm 26 mm, 304.126 (10/pkg.), 1 pkg. of each Instruments 03.501.001 Depth Gauge, for 4.5 mm Sternal Cannulated Screws 311.006 Screwdriver Handle with hex coupling, medium 311.023 Ratcheting Screwdriver Handle, 2 ea. 329.142 Combination Bending Pliers, for 2.0 mm/2.4 mm plates 329.40.98 Bending Template, 37 holes, for reconstruction plates, 2 ea. 351.026 2.7 mm Awl, hex coupling 351.027 Obturator, for Sternal Cable Passer, 37 mm 351.028 Cable Passer, for 1.0 mm Sternal Cable 351.034 4.5 mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea. Implants 4.5 mm Sternal Cannulated Screws 213.508 5 ea.: 8 mm, 9 mm, 10 mm, 11 mm and 26 mm 213.526 10 ea.: 12 mm 25 mm 4.5 mm Sternal Reconstruction Plates, 2 ea. 260.060 10 holes, 80 mm 260.062 12 holes, 96 mm 260.064 14 holes, 112 mm 260.066 16 holes, 128 mm 260.068 18 holes, 144 mm 260.070 20 holes, 160 mm 260.072 22 holes, 176 mm 260.074 24 holes, 192 mm Also Available 213.527 4.5 mm Sternal Cannulated Screws, 27 mm 213.528 4.5 mm Sternal Cannulated Screws, 28 mm 304.127 Screw Length Marker, 27 mm 304.128 Screw Length Marker, 28 mm Label Clips, for sternal plates 260.060LC for plate 260.060 260.062LC for plate 260.062 260.064LC for plate 260.064 260.066LC for plate 260.066 260.068LC for plate 260.068 260.070LC for plate 260.070 260.072LC for plate 260.072 260.074LC for plate 260.074 305.698LC for Sternal Module 305.698 305.001LC blank 8 Synthes CMF Modular Sternal Cable System
Synthes In the Service of Health Synthes is an internationally leading company in medical technology. Over 8,400 Synthes employees worldwide are involved in serving the needs of surgeons, surgical support staff and patients. Synthes a company specializing in the field of osteosynthesis develops, produces and markets surgical instruments, implants, and biomaterials for the surgical treatment of bone fractures and reconstructions of the human skeleton and its associated soft tissue. The main goal of Synthes is to provide safe and highly advanced implants, surgical instruments and technologies that enable reliable operations, fast healing and a complaint-free life after surgery. We gua rantee high quality, continuous innovation and a focused customer orientation. AO A medically-oriented nonprofit organization in the service of surgeons and patients Synthes works closely with the AO Foundation, and is licensee of the products bearing the brand name Synthes. AO stands for Arbeitsgemeinschaft für Osteosynthesefragen (Association for the Study of Internal Fixation). The foundation boasts more than 5,000 surgeons who participate in AO activities throughout the world one of the largest networks in the field of medicine. In the professional world, this surgeon-led, scientific nonprofit organization focused on treating bone fractures and diseases of the musculoskeletal system is a pioneer in research, documentation and development. The Technical Commission of the AO monitors the implementation of medical studies of new products, as a fully independent institution administered by health professionals. Only when it confirms the effectiveness and quality of a product does it award the seal of quality of the Synthes brand. Surgeons throughout the world place great trust in Synthes products because they know they have been carefully evaluated and tested. Yet even the best implants and instruments are useless if they are not used properly. AO International, the arm of the foundation responsible for training, annually organizes more than 160 AO courses throughout the world that offer practical exercises and discussions. Since the beginnings of the AO, experienced AO physicians have provided theoretical and practical training for more than 500,000 surgeons and more than 150,000 surgical support staff members. Synthes products are a familiar sight in nearly every operating room in the world. AO Foundation, Davos, Switzerland The AO Foundation offers numerous training courses worldwide. Synthes CMF 9
Synthes CMF 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 www.synthes.com 2006 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 6/08 J6131-C