510(k) Report

Devices descending from K133834

21 later devices reach Depuy Global Unite Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+1K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+1K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+2K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+2K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+2K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+3K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+5K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+6K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—