510(k) Report

Devices descending from K936159

161 later devices reach Natural-Knee II System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+1K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+1K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233—
+1K102578Apex PS Knee SystemOmni Life Science, Inc.20118—
+1K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp.2009421
+1K032522Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc.200427—
+2K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+2K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+2K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+2K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+2K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+2K230078TRAX® CR Total Knee SystemAmplitude20230—
+2K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+2K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+2K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+2K222570COPAL knee mouldsHeraeus Medical GmbH20231—
+2K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+2K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.20210—
+2K201611Apex Knee SystemOmnilife Science20210—
+2K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+2K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+2K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+2K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+2K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+2K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+2K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+2K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+2K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+2K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+2K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+2K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+2K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+2K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+2K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+2K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K112891Apex Revision Knee SystemsOmni Life Science, Inc.201251
+2K111184Apex PS Knee System - PS-C InsertOmni Life Science, Inc.20112—
+2K062274Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321Tecres S.P.A.200820—
+2K050210Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc.2005248
+3K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K243024Cellbrick Knee SpacerUnited Orthopedic Corporation20240—
+3K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+3K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+3K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240—
+3K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+3K190216SpaceFlex KneeG21, S.R.L.20191—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A.20191—
+3K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K161273StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisBiomet, Inc.201738
+3K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+3K153437Apex Revision Knee SystemOmnilife Science201541
+3K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+3K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K133449Kasm Knee Articulating Spacer MoldsOrtho Development Corp.20140—
+3K101356Spacer-G and Spacer-KTecres S.P.A.201119—
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.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—
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+4K213287StageOne Knee Cement Spacer MoldsBiomet, Inc.20220—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+4K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+4K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101