Arthrosurface Gains FDA Clearance for OVOMotion Stemless Total Shoulder

By Julie A. Vetalice

Arthrosurface received FDA 510(k) clearance to market the OVOMotion™ Shoulder Arthroplasty system, a stemless total shoulder to treat damage from arthritis, trauma or Avascular Necrosis.

The design combines anatomic restoration with an aspherical head, and is cleared for use with the company's Inlay Glenoid system. Studies have shown that the non-spherical head optimizes the shoulder's natural movement, while the inlay glenoid showed no loosening at 4,000 cycles vs. onlay designs, which were clinically loose after ~1,100 cycles. (The inlay component launched in the EU last year.)

Per Steve Ek, Chief Executive Officer, OVOMotion is "intended to be the first of a three-element modular stemless system that will ultimately allow surgeons to intra-operatively choose between stemless, traditional and reverse options."

Sources: Arthrosuface, Inc.; ORTHOWORLD Inc.

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory