510(k) Report

Devices descending from K112144

23 later devices reach Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193175Lateralized GlenosphereMedacta Inernational SA20201—
+1K170452Medacta Shoulder SystemMedacta International S.A.201712—
+1K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+2K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+2K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+2K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+2K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+2K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+3K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+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—