DePuy Orthopaedics Receives FDA PMA Supplement Approval for TRUMATCH® Personalized Solutions with SIGMA® Rotating Platform (RP) Knee System
Warsaw, IN – Feb. 15, 2012 – DePuy Orthopaedics, Inc. (DePuy) has received Premarket (PMA) Supplement Approval from the U.S. Food and Drug Administration (FDA) for use of TRUMATCH® Personalized Solutions with DePuy’s SIGMA® RP Knee System.
TRUMATCH Solutions for use with DePuy’s SIGMA Fixed Bearing Knee System was previously cleared in August 2011, making DePuy the only orthopaedic company to have personalized instrumentation for use with both rotating platform and fixed bearing knees.
“We’re very excited about the opportunity to offer patients the world’s leading mobile bearing knee system, the SIGMA RP Knee, with TRUMATCH Personalized Solutions,” said Andrew Ekdahl, President, DePuy Orthopaedics. “This approval means patients can now benefit from precise implant positioning, enabled by TRUMATCH Solutions, and the proven performance of both the SIGMA RP and Fixed Bearing Knee Systems, while increasing efficiency in the operating room.”
TRUMATCH Personalized Solutions, which is available in 17 countries, is a surgical instrumentation and computer software system that is designed to aid in both knee implant positioning and procedure efficiency:
- TRUMATCH Solutions is the first system to utilize CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. TRUMATCH Solutions enables precise positioning of the knee implant, which is critical to its overall performance.[i], [ii], [iii], [iv]
- To improve procedure efficiency, TRUMATCH Solutions uses CT scans, rather than MRIs, for improved bone imaging, less scanning time and lower costs.[v] Procedures with TRUMATCH Solutions also require less instrumentation and eliminate up to nine surgical steps compared to total knee replacement performed without TRUMATCH Solutions.
The PMA supplement approval for TRUMATCH Personalized Solutions with the SIGMA RP Knee System is the second FDA approval that DePuy has received in the past three months for the SIGMA Knee System. In December 2011, DePuy received FDA approval for AOX™ Antioxidant Polyethylene, a next generation polyethylene material, which was approved for use with the SIGMA RP Knee System. AOX Antioxidant Polyethylene was also approved for use with DePuy’s LCS® COMPLETE® Mobile Bearing Knee System.
SIGMA® Knee System
The SIGMA® Knee System, which includes fixed bearing and rotating platform options, is the leading knee system in the U.S. and has been provided for nearly 1.7 million patients.[vi] According to the National Joint Registry for England and Wales, at five years, more than 98% of the SIGMA Knees were still in use.[vii]
One SIGMA Fixed Bearing Study has shown that 10 years after surgery, 99.6% of patients still depend on SIGMA Knees and most reported excellent relief of pain, improved range of motion and better function of the knee.[viii] SIGMA Fixed Bearing Knees are based on the clinically proven P.F.C.® Knee.[ix] SIGMA Rotating Platform Knees allow more natural movement with less wear to the implant than traditional knee replacements.[x]
Important Safety Information
The performance of knee replacements depends on age, weight, activity level, and other factors. There are potential risks and recovery takes time. People with conditions limiting rehabilitation should not have this surgery. Only an orthopaedic surgeon can determine if knee replacement is indicated based on an individual patient’s condition.
About DePuy Orthopaedics
DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, and trauma and extremities as well as bone cement and operating room products. It is part of the DePuy Family of Companies, which has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision – Never Stop Moving® – to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. Visit www.depuy.com for more information.
Belinda Mager (212) 527-7535
Jessica Masuga (574) 371-4830
[i] Werner, F. et al. “The effect of valgus/varus malalignment on load distribution in total knee replacements.” Journal of Biomechanics. 2005;38:349-355.
[ii] Cates, H. et al. “Intramedullary Versus Extramedullary Femoral Alignment Systems in Total Knee Replacement.” Clinical Orthopaedics and Related Research. 1993;286:32-39
[iii] Ritter, M. et al. “Postoperative Alignment of Total Knee Replacement,” Clinical Orthopaedics and Related Research. 1994; 299:153-156.
[iv] Sorrells, B. et al. “The effect of varus and valgus deformity on results of cementless mobile bearing TKA.” The Knee. 2007;14:284-288.
[v] D. White, K. L. Chelule, B. B. Seedhom. Accuracy of MRI vs CT imaging with particular reference to patient specific templates for total knee replacement surgery. Int J Med Robotics Comput Assist Surg 2008; 4: 224–231.
[vi] Data on file at DePuy Orthopaedics, Inc.
[vii] National Joint Registry for England and Wales 2011 Annual Report (Table 3.36, page 161).
[viii] Dalury, et al. Midterm results with the P.F.C. SIGMA Total Knee Arthroplasty System. The Journal of Arthroplasty. 2008; 23: 175-181.
[ix] Dixon M., et al. “Modular Fixed-Bearing Total Knee Arthroplasty with Retention of the Posterior Cruciate Ligament. A Study of Patients Followed for a Minimum of Fifteen Years.” The Journal of Bone and Joint Surgery Am. 2005; 87:598-603.
[x] McNulty DE, Swope SW, Auger DD, Smith T. The effect of crosslinking UHMWPE on in vitro wear rates of fixed and mobile bearing knees. ASTM STP 1445. Gsell, R. et al. American Society for Testing and Materials, West Conshohocken, PA. Available online at www.astm.org (2004).