510(k) Report

Devices descending from K121220

20 later devices reach Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+1K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+1K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+1K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+2K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+2K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+2K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+2K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+2K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+3K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—