510(k) Report

Devices descending from K030259

331 later devices reach Amatomical Shoulder with Removable Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201315PERFORM Humeral System – StemTornier, Inc.2020111
+7K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+7K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+7K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+8K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+8K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+10K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—