Sulzer Orthopedics Joint & Fracture Care

Transcription

1 Sulzer Orthopedics Joint & Fracture Care Natural-Knee Family Anatomic design for superior clinical results. Natural-Knee

2 Natural-Knee Family: A solution for every knee. Asymmetric design increases coverage of the proximal tibia. A study measuring the differential between the medial and lateral condyles of 100 cadaveric tibias showed the medial condyle is larger by 4-5 millimeters. Matching this asymmetric shape eliminated the problems associated with underfilling or overhanging. Ultracongruent insert provides posterior stabilization without bone sacrifice. This innovative design provides continuous stabilization throughout the range of motion. The Natural-Knee Family offers a complete range of interchangeable, anatomically designed implants with more than a decade of proven clinical results. The Natural-Knee design includes several innovative features not found in other systems in fact, Sulzer Orthopedics enjoys many industry firsts associated with the Natural-Knee such as the introduction of our proprietary Cancellous-Structured Titanium TM (CSTi TM ) porous coating which revolutionized the industry. Industry firsts. Deepened patellar groove maximizes range of motion. Our groundbreaking deepened patellar groove design replicates the human anatomy to allow smooth articulation of the patella through full range of motion. Restoration of natural kinematics decreases postop patellofemoral complications. CSTi porous coating for biologic fixation. In 1984, Sulzer Orthopedics introduced Cancellous-Structured Titanium (CSTi) porous coating which revolutionized the industry. This CSTi process allows us to combine a cobalt-chrome articulating surface with the biocompatibility of a titanium coating for stable fixation and outstanding clinical results. Natural-

3 Our clinical results speak for themselves. A multicenter IDE study involved 13 sites while most other implant manufacturers can only provide clinical outcome data reported by their own designing surgeons. In addition to outstanding MHSS scores, results from this study also showed a cumulative component survivorship of 99.6 percent at 7 years. Sulzer Orthopedics Inc., Natural-Knee IDE Findings: Total Knee Arthroplasty, Multicenter, Long-term Experience Using Asymmetric Tibial Tray and a Deep Trochlear-Grooved Component, Clinical Results: Natural-Knee Average MHSS Scores Preop Postop Many competitors are revising their implant designs to introduce the deep patellar groove that is an original design feature of our Natural-Knee system. Our 6 to 10 year follow-up study proves that our original design delivers outstanding clinical results. Christopher J. Evanich, MD, et al., 6- to 10-Year Experience Using Countersunk Metal-backed Patellae, The Journal of Arthroplasty 12(1): Clinical Results: Natural-Knee Deep Patellar Groove Follow-up Testing at 6-to-10 Years (7.6 Year Mean) 201 Surviving Implants 10 Revisons 1 Revision Due to Isolated Patella Wear Our Natural-Knee implants are gamma irradiated in an Oxygenless Packaging TM environment which leads to crosslinking of the polymer chains and, as shown in independent lab testing, results in poly with lower wear potential. We provide an active oxygen absorber to ensure that oxygen will not be present in the package Independent Wear Testing: Harry McKellop, PhD Nonsterilized Gamma Plasma Hylamer Oxygenless Packaging results in 53 percent reduction in wear, as shown in independent testing: H. McKellop, et al., Effect of Sterilization Method on the Wear Rate of UHMW Polyethylene Acetabular Cups in a Hip Simulator, presented at ORS, San Francisco, February In vitro wear tests have not been shown to correlate with clinical wear mechanisms Gamma in Air Gamma with Oxygenless Packaging Cycles (millions) nee Family

4 Cruciate Retaining System The Natural-Knee cruciate retaining system closely mirrors the knee s anatomic form to improve function. Our femoral components offer the first truly deepened patella groove to maximize range of motion and minimize patellar complications. Posterior Stabilized System The Natural-Knee posterior stabilized system provides two proven methods to improve stability in the absence of the posterior cruciate ligament: a boneconserving ultracongruent insert and our traditional cam-and-post design. Revision Total Knee Systems The components in our Natural-Knee Revision Systems restore kinematic function; enhance stability; and compensate for bone loss in the revision arthroplasty patient. System modularity and varying levels of constraint give surgeons the intraoperative flexibility to suit a broad range of patient needs and surgical preferences. nee Family

5 High Tibial Osteotomy System The Natural-Knee High Tibial Osteotomy System is specifically designed for young, active patients with varus and valgus deformities. Our HTO system was the first to deliver reproducible results by providing a precise, simple to use, alternative to freehand methods. Unicompartmental System For patients with unicompartmental disease, the unicompartmental implant provides a cost-effective, clinically proven alternative to tricompartmental knee replacement. The system uses Natural-Knee instrumentation to allow the surgeon to achieve reproducible results. Precise instrumentation critical to surgical success. Like fine Swiss watches, our instruments are designed with precision to help surgeons achieve reproducible results implant after implant. The complete line of Natural-Knee implant products share common instrumentation and surgical techniques. One critical factor in our clinical success is that our instrumentation is scientifically designed to help the surgeon match each patient s individual anatomy and kinematics other systems often require the surgeon to alter the patient s anatomy to fit the prosthetic design. Meeting surgical preference for cemented and cementless applications. As a result of innovations such as CSTi, the Natural-Knee primary components are one of only three knee implant systems permitted for use without cement in the United States.

6 Sulzer Orthopedics Innovators in Medical Device Technology Knees Apollo Knee System Classic condylar knee replacement system. MOST TM System Modular knee and hip options for severe bone loss and trauma. Natural-Knee System Anatomic design for superior clinical results. Hips Alloclassic TM Hip Classic proven design with superior clinical results. APR Anatomical Hip System Anatomically designed hip replacement system. Durasul TM Tribological System Highly crosslinked polyethylene without measurable wear. FracSure TM Hip System A classic design for hip fractures. Inter-Op TM Acetabular System Leading-edge technology in a porous acetabular system. Metasul Metal-on-Metal Acetabular Components Backed by a limited Lifetime Warranty and over 10 years of clinical results. Natural-Hip TM System A complete, state-of-the-art hip system. MS-30 TM Hip A highly polished cemented stem. Precedent TM Revision Hip System A better solution for revision hips. SL Revision TM Hip System A stable revision design with extensive sizes. Upper Extremities Sulzer Orthopedics Inc Spectrum Drive Austin, Texas fax: Anatomical TM Shoulder System Infinite adjustments of inclination & retroversion for precisely restored anatomy. GSB III Elbow System A nonconstrained design with 21 years of successful clinical results. Select Shoulder System TSA and fracture management with offset head options Sulzer Orthopedics Inc. All rights reserved. Posterior stabilized, revision, constrained, unicompartmental, and all-poly components of the Natural-Knee family are intended for cemented use only. Natural-Knee, Cancellous-Structured Titanium, and CSTi are trademarks of Sulzer Orthopedics Inc. The Independent Wear Testing reported in this brochure was performed on a 12-station hip simulator (Shorewestern, Monrovia, CA) with the cup oriented below the head. The load was applied through CoCr heads with a maximum load of 2000 N and a wave form representative of the Paul s cycle. The solution used for testing was bovine calf serum with 0.2 mmole EDTA and 0.2 percent sodium oxide. Wear rates were based on graviometric analysis with a sample size of n=2 and two parts per condition being used for soak control. Products are distributed in Europe by Sulzer Orthopedics Ltd., Grabenstrasse 25, CH-6341, Baar, Switzerland, 011 (41) ; in Canada by Sulzer Orthopedics Canada, Inc., 265 Bartley Drive, Toronto, Ontario, Canada M4A2N7, (416) ; in Australia by Sulzer Orthopedics Australia, Level 5, 384 Eastern Valley Way, Chatswood, NSW 2067, Australia, ; and in Japan by Sulzermedica Japan K.K., Itopia Eitai Bldg. 7F 1-3-7, Saga, Koto-Ku, Tokyo , Japan, /00 5,000 info@sous.com