Biomet Gets 510(k) Clearance for Hip Replacement Device

A new hip replacement device from Biomet Inc. received 510(k) clearance from the U.S. Food and Drug Administration late last week.

The Active Articulation E1 dual mobility hip system utilizes a small femoral head that articulates with polyethylene. When triggered, the large polyethylene bearing acts as a large head bearing that articulates within a metal cup. The system will compete against hip replacement devices from Stryker Corp. and Zimmer Holdings Inc.

“The [system] provides an excellent combination of wear resistance and implant stability,” John Serbousek, Biomet U.S. orthopedics division president, said in prepared remarks.

Biomet, based in Warsaw, Ind., reported losses of $11.6 million on sales of $678 million in the third quarter. The loss compares with losses of $3.1 million on sales of $668.8 million in the same period last year.