510(k) Report

Devices descending from K143659

5 later devices reach Equinoxe Mega Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+1K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+1K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+2K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+3K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501