FDA clears Zimmer Biomet’s elbow-shoulder combo

Zimmer Biomet (NYSE:ZBH) said today that the FDA cleared the combination of its Nexel total elbow system and the Comprehensive segmental revision system, which the company said was its 1st clearance seeking to make 2 separate systems compatible.

The Warsaw, Ind.-based orthopedics titan said the 510(k) clearance allows for a complete elbow replacement with the Nexel device, while providing for later shoulder reconstruction procedures using the Comprehensive device.

“The compatibility of the Comprehensive SRS system with the Nexel total elbow is another example of how the combined Zimmer Biomet extremities portfolio supports surgeons in addressing difficult revision, deformity and fracture cases,” vice president Orsa Britton said in prepared remarks. “Our commercial teams are very excited about the opportunities signaled by this recent FDA clearance, as well as the ongoing opportunity to meet our customers’ needs with our market-leading, broad and innovative range of extremities solutions.”

“The ability to link the clinically proven Comprehensive SRS system with a reliable total elbow system like the Nexel provides surgeons with multiple strategies to treat patients with excessive bone loss at the distal humerus,” added Dr. Peter Evans of the Cleveland Clinic. “The straightforward and efficient instrumentation of both systems also facilitates proper humeral and ulnar length, as well as soft tissue tension.”

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