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DePuy Orthopaedics receives FDA 510(k) clearance for titanium foam implants

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DePuy Orthopaedics, Inc. announced in a press release that it has received FDA 510(k) clearance for the use of GRIPTION TF, a commercially pure titanium foam, in two new implant systems for complex joint replacement procedures.

According to a DePuy Orthopaedics press release, 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, according to the release. 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.

According to the press release, 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,” David Floyd, worldwide president of DePuy Orthopaedics, Inc., stated in the press release. “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.”