510(k) Report

Devices descending from K974044

440 later devices reach Global Total Shoulder Eccentric Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+7K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+7K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+7K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+7K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+7K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+7K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+7K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+8K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+8K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+8K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+8K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+8K210153NextAR RSA PlatformMedacta International S.A.202151
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+9K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+10K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—