510(k) Report

Devices descending from K193373

20 later devices reach Comprehensive® Reverse Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+1K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+1K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+1K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+1K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+1K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+1K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+2K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+2K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+2K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+2K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+2K241043Augment Off-Axis Instrument SystemFix Surgical202415
+2K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+2K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+2K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+3K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—