510(k) Report

Devices descending from K914000

235 later devices reach Global (TM) Total Shoulder W/Dupont Enhanced Uhmwpe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+7K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+7K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+7K152966Aequalis Fx2Tornier S.A.S.201601
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K254003JARVIS Metaphyseal StemFH Industrie20260—
+8K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+8K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K240876Identity Shoulder SystemZimmer, Inc.20241—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+8K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+8K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+8K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+8K210153NextAR RSA PlatformMedacta International S.A.202151
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+9K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+9K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+10K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—