DePuy receives FDA premarket supplemental approval for TRUMATCH system

DePuy Orthopaedics Inc. has received premarket supplement approval from the FDA for use of TRUMATCH Personalized Solutions with DePuy’s SIGMA RP Knee System. The system was previously cleared in Aug. 2011 for the SIGMA Fixed-Bearing Knee System, making DePuy the only orthopedic company to offer personalized instrumentation for use with both rotating platform and fixed bearing knee prostheses, according to a company release.

“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,” Andrew Ekdahl, president of DePuy Orthopaedics, stated in the release. “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,” he stated.

TRUMATCH Personalized Solutions, according to the release, is a surgical instrumentation and computer software system designed to aid both knee implant positioning and procedure efficiency.

Value Pricing Leader IFS Now Marketing Subtalar Implants

Internal Fixation Systems, a Miami, Florida, company founded in 2006, has received 510(k) clearance from the FDA to market its subtalar implants. Made of stainless steel, with a cylindrical shape and tapering on one or both ends, the devices are designed to preserve motion at the ankle joint and deal with arthritis as well as whatever trauma the patient has experienced.

IFS’s CEO, Stephen Dresnick, M.D., says that his firm also currently offers a full line of mini-cannulated screws for small bone fixation as well as a Modular Locking Small Fragment System for treatment of bone fractures and osteotomies.

In describing IFS, Dresnick said that the company takes products that have been around for a long time and made by various companies, such as subtalar implants, and figures out how to make them better. He presents the established designs to his panel of recognized surgeons for analysis and modification and the addition of doctor—recommended enhancements. Dresnick then manufactures and sells the devices for 40% to 60% less than the competition.

“We are a value-priced company,” Dresnick told OTW. “We try to build our products inexpensively. They presently cost too much. Medicare is no longer willing or able to pay separately for implants.” IFS customers include ambulatory surgery centers, hospitals and orthopedic surgeons.

Smith & Nephew plc Announces Result Of New Study For BIRMINGHAM HIP Resurfacing (BHR) System

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, today announced the results of a new study for its BIRMINGHAM HIPT Resurfacing (BHR) System. The study, carried out at the request of the FDA, followed the progress of the first 400 BHR patients in the United Kingdom and found that after 10 years, 99% were either satisfied or extremely satisfied with their BHR procedure.

"These results further exemplify why the BHR Hip is unlike any other metal-on-metal implant," says John Soto, Senior Vice President for Smith & Nephew's Global Hip Franchise. "Not only does the BHR Hip offer all the advantages of hip resurfacing, including bone-conservation, greater range of motion and decreased risk of dislocation, but it does so while maintaining implant survivorship rates that are on par with, or in some patient populations even better
than, traditional total hip replacement which has long been considered the most successful orthopaedic surgical procedure for relieving chronic pain."

FDA issues guidance on IDEs for knee cartilage repair/replacement devices and drugs

The FDA issues new guidance on proper submissions for investigational device exemption and investigational new drug applications for products intended to repair or replace knee cartilage.


The FDA this week issued new guidance on getting clearance for clinical trials of products intended to repair or replace knee cartilage.

The guidance covers devices, biologics and hybrid products, outlining required items to include in submission documents for investigation device exemption or investigation new drug applications.

J&J's Depuy to stop selling all custom devices in response to FDA warning

Johnson & Johnson subsidiary Depuy Orthopaedics decides to stop selling all custom devices following an FDA letter warning the company to file new PMA and 510(k) applications for several components.