510(k) Report

Devices descending from K153398

3 later devices reach Comprehensive SRS/Nexel Elbow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+2K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+3K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501