510(k) Report

Devices descending from K003566

28 later devices reach Cofield Eccentric and Lateral Offset Humeral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+1K070565Cofield Total Shoulder SystemSmith & Nephew, Inc.200726—
+1K030344Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral HeadsSmith & Nephew, Inc.20030—
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+6K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+6K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+7K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+7K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+7K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+8K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+8K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+8K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+8K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+8K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+9K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+9K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+9K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+9K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+10K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+10K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—