WARSAW — Zimmer Biomet Holdings Inc., a global leader in musculoskeletal healthcare, is pleased to announce that the company has received 510(k) clearance from the U.S. Food and Drug Administration for the compatibility of the Nexel Total Elbow System with the Comprehensive Segmental Revision System. This 510(k) clearance marks the first submission by the Company to establish the compatibility of two separate Zimmer Biomet implant systems.
The distal component of the comprehensive SRS humeral system, when combined with the Nexel Total Elbow System, is designed for elbow replacement, while the remaining components allow for proximal or total humeral reconstruction when used with the glenoid component of the comprehensive Shoulder System.
“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,” said Dr. Peter J. Evans, director of the Upper Extremity Center at the Cleveland Clinic. “The straightforward and efficient instrumentation of both systems also facilitates proper humeral and ulnar length, as well as soft tissue tension.”
In addition to addressing proximal, distal or complete humeral replacement, the ability of the comprehensive SRS and Nexel Total Elbow to interact with the Regenerex tissue attachment augments addresses concerns regarding graft availability and resorption as well as providing tissue stabilization and attachment points.
“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,” said Orsa Britton, vice president and general manager of the global Extremities business. “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.”
For more information on the comprehensive SRS and Nexel Total Elbow, visit zimmerbiomet.com.