Arthrocare Hip Implant Cleared Amid Accounting Investigation

Austin, Texas-based Arthrocare Corporation has received 510(k) clearance from the U.S. Food and Drug Administration for its Speedlock hip knotless fixation implant. The Speedlock hip is a PEEK (polyetheretherketone) implant that is indicated for soft-tissue fixation to bone in the hip. The implant, according to the company, is designed to provide a precise and stable construct with a streamlined technique, and is primarily used in acetabular labral reattachment and hip capsular repair.

The product release comes at a time the company is embroiled in an investigation by the U.S. Department of Justice (DOJ) for activities related to past sales, accounting and billing procedures of its spine product sales. According to a filing with the Securities and Exchange Commission, the DOJ also is investigating Arthrocare’s relationship with its Discocare Inc. division, a third-party billing company that Arthrocare bought in 2008.

Arthrocare manufactures surgical devices, instruments,and implants. Many of Arthrocare’s devices use its patented Coblation technology, which is reported to precisely dissolve target tissue and limits damage to surrounding healthy tissue. The company is currently attempting to break into the sports medicine; ear, nose and throat; spine; wound care; urology; and gynecology surgical markets.