510(k) Report

Devices descending from K992119

419 later devices reach Bio-Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+4K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+5K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+5K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K250848Identity Shoulder SystemZimmer, Inc.20250—
+5K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+5K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+5K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+5K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+5K202338SpaceFlex ShoulderG21, S.R.L.20211—
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+5K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+5K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+5K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+5K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+5K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+5K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+5K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+5K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+5K150730Zimmer PSI Shoulder SystemZimmer201511—
+5K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+6K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+6K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+6K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+6K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+6K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+6K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+6K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+6K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+6K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+6K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+6K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+6K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+6K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+7K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K243509Archer PSI System3D-Side20250—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+7K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+7K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+7K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—