510(k) Report

Devices descending from K062661

16 later devices reach Aequalis Resurfacing Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+1K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+1K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+2K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+2K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+2K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+2K141345Aequalis FX2Tornier S.A.S.201411
+3K240876Identity Shoulder SystemZimmer, Inc.20241—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+3K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+3K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+3K152966Aequalis Fx2Tornier S.A.S.201601
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—