Biomet wins FDA clearance on two new products

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The FDA has cleared Biomet to sell its E1 humeral bearing and Comprehensive Segmental Revision systems.

Biomet stated it designed the E1 for use with hip and knee devices. The company adapted the technology, which uses vitamin E to provide oxidative stability, for its Comprehensive Reverse Shoulder product line.

Comprehensive Segmental Revision is a system for replacing the humerus, typically in patients with bone cancer. The company designed it to be compatible with its shoulder and elbow systems.

Warsaw, Ind.-based Biomet’s primary market is musculoskeletal surgery.