Gabrielle M. Lee (212) 527-7538
Jessica Masuga (574) 371-4830
DEPUY ORTHOPAEDICS RECEIVES FDA 510(k) CLEARANCE
FOR NEW TITANIUM FOAM IMPLANTS
WARSAW, IN – February 14, 2011 – DePuy Orthopaedics, Inc. (DePuy) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of GRIPTION® TF, a commercially pure titanium foam (TF), in two new implant systems for complex joint replacement procedures.
The DePuy GRIPTION® TF Acetabular Augment System for hip replacement surgery and the DePuy Universal GRIPTION® TF Cones for knee replacement surgery mark the first time the company has offered implants made entirely from its proprietary GRIPTION TF technology. GRIPTION TF is a highly porous structure made from commercially pure titanium; a strong, corrosion-resistant metal that has high surface roughness and a similar elasticity to bone.
The GRIPTION TF Acetabular Augment System fills the gap between the acetabular bone and cup in patients with severe bone defects. The GRIPTION TF Acetabular Augment System provides advances in fixation, materials and instrumentation, all of which are critical to achieving successful patient outcomes. The components of the system are engineered to provide a wide range of options and configurations so that each patient’s implant components can be customized at the time of surgery.
The DePuy Universal GRIPTION TF Cones for knee replacement surgery can be used with the tibial or femoral component in patients with marked bone loss, providing surgeons with additional options when faced with a complicated revision total knee replacement. The GRIPTION TF Cones, available in many sizes to meet the needs of each individual patient, are fully compatible with DePuy’s Sigma® Knee System.
“DePuy’s GRIPTION TF System features several unique advances to create customized intraoperative solutions for patients who require complex revision surgery,” said David Floyd, Worldwide President, DePuy Orthopaedics, Inc. “With DePuy’s GRIPTION TF technology, surgeons will be able to more confidently address even the most challenging defects in conjunction with our Pinnacle® Acetabular Cup System.”
The performance of a hip or knee replacement depends on a patient’s 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. Patients should consult with an orthopaedic surgeon to determine if hip or knee replacement surgery is appropriate for them.
About the DePuy Companies
DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, extremities, and trauma, 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.