Biomet Launches Patient-Specific Shoulder Instrument Line in the U.S.

Biomet Orthopedics recently announced the first clinical use of the Signature patient-specific glenoid instrumentation in the United States. The glenoid cavity is part of the shoulder. The Signature glenoid system was introduced in Europe in February 2013, and is used in conjunction with the company’s Comprehensive shoulder replacement system.

The company received U.S. Food and Drug Administration 510(k) clearance for the system in early August.

Signature glenoid guides use CT imaging data and a proprietary algorithm to match each patient’s anatomy and facilitate proper positioning of the glenoid component. The preoperative planning tool allows surgeons to make any necessary adjustments required for each patient, including component size, inclination and version, prior to surgery, according to the company.

Biomet officials claim that the Signature glenoid guide is the only device of its type that features a patent-pending dual trajectory, allowing surgeons to elect a reverse or total shoulder procedure intraoperatively.

“Signature is a major advance in shoulder arthroplasty,” said John W. Sperling, M.D., orthopedic surgeon in Rochester, Minn., and a participant in the product development of the Signature glenoid system. “In addition to providing a time-efficient and user-friendly solution to consistently place the glenoid component, Signature provides the surgeon the ability to seamlessly choose between anatomic and reverse shoulder arthroplasty.”

“Given the inherent exposure and orientation challenges in total shoulder arthroplasty, this technology is ideally suited for the shoulder,” said Jason M. Hurst, M.D., orthopedic surgeon with Joint Implant Surgeons in New Albany, Ohio, and also a participant in the product development of the new system. “With my initial experiences … the pre-operative plans were well replicated by the guides and very easy to use. I believe that this tool provides me with reliable implant positioning.”

The Signature glenoid system is the latest addition to Biomet’s portfolio of patient-specific instrumentation technology. The Signature knee system has been used in more than 80,000 surgeries since its introduction in 2007. Warsaw, Ind.-based Biomet also recently introduced Signature instrumentation for acetabular positioning in total hip replacement. Signature knee and hip technology are collaborative partnerships with Materialise N.V., a Belgium-based company specializing in clinical engineering, rapid prototyping and 3-D printing.