510(k) Report

Devices descending from K103419

22 later devices reach Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+1K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+2K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+2K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+3K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+3K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+7K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—