510(k) Report

Devices descending from K131353

60 later devices reach Comprehensive Reverse Shoulder - Titanium Glenosphere through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+1K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+1K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+1K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+1K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+2K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+2K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+2K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+2K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+2K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+2K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+2K240876Identity Shoulder SystemZimmer, Inc.20241—
+2K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+2K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+2K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+2K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+2K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+2K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+2K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+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—
+3K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—