510(k) Report

Devices descending from K981487

335 later devices reach Depuy Global Shoulder Glenoid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+7K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+7K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+7K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+7K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+9K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—