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
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K163332Apex Revision Knee SystemOmnilife Science20173—
+4K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+4K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+4K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+4K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+4K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+4K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+4K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+4K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+4K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+4K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+4K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+4K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+4K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+4K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+4K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+4K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+4K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+4K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation2009505
+5K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K241470CORE Shoulder SystemLinkBio Corp.202501
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K201084Physica systemLima Corporate S.P.A.20205—
+5K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+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—
+5K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+5K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+5K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+5K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+5K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+5K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+5K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163—
+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—
+5K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+5K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+5K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+5K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+5K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+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—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+6K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+6K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—