510(k) Report

Devices descending from K062250

250 later devices reach Delta Xtend Reverse Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+6K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K210153NextAR RSA PlatformMedacta International S.A.202151
+6K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+6K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+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—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+7K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+7K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+7K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+7K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+7K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+7K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+9K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—