510(k) Report

Devices descending from K933785

328 later devices reach Next Generation Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation20170—
+3K160700ATTUNE Revision Knee SystemDepuy (Ireland)201665
+3K153657Vanguard XP Knee SystemBiomet, Inc.201611
+3K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K143635KINETIS Total Knee SystemMako Surgical20150—
+3K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+3K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+3K142069GMK ExtensionMedacta International20144—
+3K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+3K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K140826GMK Sphere ExtensionMedacta International201417—
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+3K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+3K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+3K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+3K131368Neo Knee SystemPipeline Orthopedics20131—
+3K131310GMK Full PE Tibial ComponentsMedacta International20132—
+3K123721GMK Revision ExtensionMedacta International20133—
+3K122500Neo PS Knee SystemPipeline Orthopedics20131—
+3K123486Triathlon Tritanium Tibial BaseplateStryker2013517
+3K122232GMK NarrowMedacta International20128—
+3K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+3K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+3K121416GMK SphereMedacta International201220—
+3K120790GMK - Line ExtensionMedacta International201211—
+3K113571GMK Resufacing Patella Size 4Medacta International201223—
+3K111283GMK Revision Hybrid LinersMedacta International20110—
+3K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+3K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+3K102437GMK Revision Knee SystemMedacta International S.A.201034—
+3K093806Myknee Cutting BlocksMedacta International S.A.201016—
+3K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+3K071107Gender Solutions Natural-Knee Flex System; Nex Gen Complete Knee Solution CR-Flex Gender…Zimmer, Inc.200705
+3K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc.20071225
+3K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc.200712363
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.20260—
+4K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+4K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+4K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+4K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+4K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+4K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K231037MyKnee UNI-STMedacta International S.A.20230—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+4K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+4K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+4K210062Mectaplug PE IIMedacta International S.A.20210—
+4K210554Physica systemLima Corporate S.P.A.20212—
+4K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+4K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+4K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+4K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+4K171365Arthrex Knee SystemsArthrex, Inc.20170—
+4K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+4K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+4K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+4K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+4K162035GMK SphereMedacta International S.A.201710—
+4K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+4K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+4K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+4K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+4K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+4K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+4K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+4K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+4K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+4K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+4K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics20142811
+4K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics2013381
+4K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+4K110950Consensus Knee SystemConsensus Orthopedics, Inc.201114—
+4K103721Mpact Acetabular SystemMedacta International201121—