510(k) Report

Devices descending from K943462

428 later devices reach Darwin Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+5K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+5K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+5K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+5K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K201084Physica systemLima Corporate S.P.A.20205—
+5K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+5K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+5K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+5K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.20201—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+5K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+5K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+5K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+5K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+5K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K171365Arthrex Knee SystemsArthrex, Inc.20170—
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+5K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+5K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+5K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+5K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+5K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+5K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+5K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+5K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+5K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+5K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+5K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.201525—
+5K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+5K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+5K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+5K131129Cas Psi ShoulderZimmer Cas201339—
+5K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+5K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+6K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+6K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+6K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.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—