510(k) Report

Devices descending from K913282

17 later devices reach Lima RPS Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022079Short and Long Soft Tissue AttachmentBiomet, Inc.200216—
+2K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+2K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc.2003151
+3K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+3K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+3K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+3K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC201252
+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—
+4K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+4K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+4K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc.20190—
+4K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+4K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp.20121—
+4K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501