510(k) Report

Devices descending from K003253

24 later devices reach Biomet's Minimally Constrained Elbow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013042Discovery ElbowBiomet Orthopedics, Inc.2001233
+2K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+2K181362TEMA Elbow SystemLima Corporate S.P.A.201911
+2K090473Discovery Elbow - X-SmallBiomet Manufacturing Corp20092—
+2K051975Porous Coated Discovery ElbowBiomet, Inc.2005112
+2K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc.2003151
+3K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.202201
+3K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+3K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC201252
+3K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+3K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc.20058—
+3K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp20059—
+3K042664LPS Upper ExtremityDepuy, Inc.20040—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc.20190—
+4K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+4K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+4K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+4K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp.20121—
+4K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+5K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+5K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+5K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501