510(k) Report

Devices descending from K113121

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+1K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+1K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+1K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+2K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+2K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+2K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+2K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+2K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+2K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+2K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+2K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+2K193099Anatomical Shoulder SystemZimmer GmbH20201—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K260556Veritas Shoulder SystemRestor3D20260—
+3K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+3K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+3K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K241043Augment Off-Axis Instrument SystemFix Surgical202415
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K243248Inhance Intact™Depuy Ireland UC20240—