Biomet Receives FDA Clearance For Two New Shoulder/Elbow Products

“This system (SRS) is particularly helpful for surgeons specializing in revision shoulder or elbow surgery where modularity and intra‐operative flexibility is critical”

Abstract

Biomet, Inc., has announced FDA clearance of two new products; the E1® humeral bearing for use with the Comprehensive® Reverse Shoulder System, and the Comprehensive® Segmental Revision System.

Antioxidant-Infused Humeral Bearing

The E1® humeral bearing with exclusive Antioxidant‐Infused Technology is the first Vitamin E advanced bearing option for reverse shoulder applications the company having first applied the technology to its hip and knee products. The integration of E1® technology into the Comprehensive® Reverse Shoulder portfolio will provide surgeons and patients with an advanced bearing surface with oxidative stability, high strength and a low wear.

“Biomet is the first company to bring advanced bearing surfaces to the shoulder,” said John Sperling, MD, orthopaedic surgeon, Rochester, Minnesota. “The outstanding wear characteristics and proven track record of E1® bearings will provide a tremendous benefit to patients undergoing reverse shoulder arthroplasty.”

Comprehensive® Segmental Revision System

The FDA also cleared Biomet’s Comprehensive® Segmental Revision System (SRS), a humeral replacement system designed to address significant bone loss, both proximally and distally. The Comprehensive® SRS offers oncologic options, soft tissue attachments, and multiple sizing options, and is compatible with the Comprehensive® Shoulder system and the Discovery® Elbow system.

“The Comprehensive® SRS is a breakthrough in shoulder and elbow arthroplasty design,” said Dr. Sperling. “This system is specifically designed to address humeral bone deficiency in revision and oncologic settings.”

“This system is particularly helpful for surgeons specializing in revision shoulder or elbow surgery where modularity and intra‐operative flexibility is critical,” said Orthopaedic Surgeon Quin Throckmorton MD, of Memphis, Tennessee.

Source: Biomet Inc.

Note disclosures: Drs. Sperling and Throckmorton are developing surgeons for the Comprehensive® Shoulder System and are paid consultants for Biomet.