510(k) Report

Devices descending from K051975

11 later devices reach Porous Coated Discovery Elbow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181362TEMA Elbow SystemLima Corporate S.P.A.201911
+1K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+1K090473Discovery Elbow - X-SmallBiomet Manufacturing Corp20092—
+2K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.202201
+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