510(k) Report

Devices descending from K081707

25 later devices reach Aequalis Shoulder Fracture and Shoulder Systems through their predicates, nearest generation first.

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