510(k) Report

Devices descending from K950010

365 later devices reach Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+6K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+6K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+6K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+6K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+6K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+6K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+6K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.20201—
+6K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+6K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+6K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+6K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+6K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+6K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+6K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+6K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+6K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+6K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+6K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+6K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+6K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+6K171365Arthrex Knee SystemsArthrex, Inc.20170—
+6K163669Humeris ShoulderFx Solutions201720—
+6K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+6K162455Humelock Reversed ShoulderFx Solutions201717—
+6K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+6K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+6K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+6K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+6K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+6K150730Zimmer PSI Shoulder SystemZimmer201511—
+6K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+6K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.201525—
+6K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+7K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+7K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+7K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+7K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—
+7K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+7K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+7K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+7K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+7K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+7K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+7K241043Augment Off-Axis Instrument SystemFix Surgical202415
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+7K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+7K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+7K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+7K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+7K203421Triathlon AS-1Conformis, Inc.20210—
+7K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+7K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+7K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+7K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+7K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+7K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+7K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+7K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+7K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+7K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+7K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+7K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+7K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+7K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—