CONMED Linvatec's Suture Anchor Receives 510(k) FDA Clearance

CONMED Corp.'s CONMED Linvatec arthroscopy unit announced that the Food and Drug Administration (FDA) has cleared its 510(k) application for marketing of the Bio Mini-Revo suture anchor for use in the repair of the labrum in the hip joint. The company recently executed a full market launch for this product.

The hip labrum is a form of cartilage that lines the rim of the socket of the hip. Torn and detached labral tissue is associated with hip pain during movement. In an arthroscopic technique, surgeons use suture anchors to reattach the torn cartilage to the rim of the socket to relieve pain and regain normal hip function.

The Bio Mini-Revo anchor is a bioabsorbable 3.1 millimeter diameter screw-in anchor manufactured from CONMED Linvatec's patented self-reinforced 96L/4D poly lactic acid. This unique material provides an optimal balance of strength (during the initial healing period post-surgery) with enhanced resorption over time, negating the need for a second surgery to remove the implant. The anchor is pre-threaded with No. 2 Hi-Fi® high strength sutures. Currently, there are no other suture anchors indicated for hip labral repair that contain the unique blend of mechanical strength and biomaterial characteristics of the Bio Mini-Revo anchor.

"Bio Mini-Revo, and the associated extended length drill guides, provides the surgeon with a safe and effective method to repair the labrum," said Christopher Dougherty, of The Agility Center in Bentonville, Ark. "The Bio Mini-Revo technique and extended length instrumentation greatly aid in hip access and minimize the risks of failed anchor fixation."

"As hip arthroscopy continues to develop as a surgical specialty, and labral repairs in particular become more prevalent, we anticipate that the Bio Mini-Revo suture anchor will become an important part of our continuously expanding hip product line," commented Mr. Joseph J. Corasanti, president and chief executive officer. "We are excited that this safe and effective implant, which has already been used successfully in thousands of surgeries in the shoulder, will now be available to our customers for use in the hip."

The Bio Mini-Revo anchor joins a growing number of products in the ConMed Linvatec Hip Arthroscopy line; including disposable hip access kits, cannulas, Shutt brand manual instruments, microfracture awls, shaver blades and burrs, and imaging and pump systems.

Source: CONMED Corp.