510(k) Report

Devices descending from K091196

23 later devices reach GRS Glenoid Resurfacing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+1K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+1K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+2K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+2K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+2K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+2K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+2K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+2K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+2K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+2K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+2K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+3K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—