510(k) Report

Devices descending from K103007

71 later devices reach Affiniti Total and Hemi-Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143552Simpliciti Shoulder SystemTornier, Inc.201524—
+1K111902Aequalis Shoulder SystemTornier201149—
+2K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+2K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+2K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+2K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20220—
+2K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+2K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+2K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+2K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+2K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+2K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+2K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+2K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+3K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+3K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+3K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K243509Archer PSI System3D-Side20250—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+4K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—