510(k) Report

Devices descending from K092873

125 later devices reach Reverse Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+8K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+8K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—