510(k) Report

Devices descending from K010664

14 later devices reach Copeland Resurfacing Humeral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.20141—
+1K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+1K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621
+1K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc.2003105
+2K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+2K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+2K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+2K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+3K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—