510(k) Report

Devices descending from K873679

259 later devices reach Select Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+5K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+5K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+5K193099Anatomical Shoulder SystemZimmer GmbH20201—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+5K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+5K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+5K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+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—
+5K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+5K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+5K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+5K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K120794Ascend Shoulder SystemTornier, Inc.201298—
+5K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+6K260556Veritas Shoulder SystemRestor3D20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K243509Archer PSI System3D-Side20250—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+6K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+6K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+6K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+6K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+6K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+6K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+6K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+6K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+6K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+6K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+6K163669Humeris ShoulderFx Solutions201720—
+6K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—