510(k) Report

Devices descending from K161863

13 later devices reach ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+1K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+3K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+4K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+4K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+5K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+5K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—