510(k) Report

Devices descending from K943462

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.20260—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+4K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+4K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+4K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+4K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+4K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+4K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+4K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+4K191814Alliance GlenoidZimmer, Inc.20194—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+4K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+4K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+4K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+4K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+4K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+4K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+4K163332Apex Revision Knee SystemOmnilife Science20173—
+4K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+4K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163—
+4K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+4K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+4K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+4K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+4K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+4K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+4K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+4K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+4K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+4K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+4K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+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—
+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—
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, 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
+5K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+5K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+5K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+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—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—