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DJO's surgical division receives FDA market clearance on product

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Vista-based DJO Inc., a provider of products and services that promote pain management and musculoskeletal and vascular health, announced that its surgical division, DJO Surgical, formerly Encore Medical, has received FDA market clearance for the company’s new X-alt highly crosslinked polyethylene liner for DJO Surgical’s FMP Acetabular Hip System.

The system combines the company’s existing Cobalt-Chrome and ceramic femoral heads with a new wear-resistant, highly crosslinked polyethylene cup liner to form the hip ball and socket joint. This liner substantially increases the resistance to ball and socket wear compared to traditional polyethylene cup liners.

In laboratory tests, the new crosslinked polyethylene liner reduced the generation of wear particles by 87 percent compared to the company’s traditional polyethylene liner, which itself offers excellent wear-resistance. Polyethylene wear debris in total hip replacement is a leading cause of osteolysis, an inflammatory response to wear particles. Osteolysis can lead to subsequent implant loosening in patients who have undergone hip replacement surgery.

DJO Surgical’s system has also been designed to reduce post-surgical hip dislocation by incorporating larger diameter femoral heads. Larger diameter heads increase the range of motion of the femoral shaft relative to the socket, reducing the chance of impingement, or the point where the femoral head will lever-out of the socket.

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