510(k) Report

Devices descending from K962315

335 later devices reach Select Shoulder Cocr Humeral Stem Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+5K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+5K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+5K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+5K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+5K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+5K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+5K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+5K141006RSP Humeral Socket InsertDjo Global2014212
+5K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+5K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+5K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+5K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+5K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+5K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+5K113413Ascend Shoulder SystemTornier, Inc.2012105—
+5K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+5K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+5K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+5K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+5K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+5K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+5K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+5K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+5K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+5K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+6K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K243509Archer PSI System3D-Side20250—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+6K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+6K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+6K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+6K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+6K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+6K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+6K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+6K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+6K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+6K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+6K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+6K120794Ascend Shoulder SystemTornier, Inc.201298—
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+7K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+7K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+7K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+7K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+7K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+7K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—