510(k) Report

Devices descending from K042321

9 later devices reach Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+1K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+2K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+2K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+2K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+3K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+3K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+3K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+4K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501