FDA Clears Compatibility of ZBH Nexel Total Elbow with the Comprehensive Segmental Revision System

By Julie A. Vetalice

Zimmer Biomet (ZBH) received FDA 510(k) clearance for compatibility of the Nexel™ Total Elbow with the Comprehensive® Segmental Revision System (SRS). This marks the 1st submission by ZBH to establish compatibility of two separate ZBH implant systems.

The distal component of Biomet's Comprehensive SRS humeral system, when combined with Zimmer's Nexel Total Elbow, is designed for elbow joint replacement, while the remaining components support proximal or total humeral reconstruction when used with the glenoid component of the Comprehensive Shoulder.

Further, the ability of Comprehensive SRS and Nexel to interact with Regenerex™ Tissue Attachment Augments addresses concerns regarding graft availability and resorption.

Source: Zimmer Biomet, Inc.


Product Labels: Shoulder Replacement, Elbow/Radial Head Replacement

Tags: 510(k) Clearance, Regulatory