510(k) Report

Devices descending from K032895

10 later devices reach BI-Angular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp20059—
+2K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+2K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+3K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+3K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+3K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+4K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+4K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+4K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501