510(k) Report

Devices descending from K033363

144 later devices reach Zimmer Unicompartmental Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+1K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+1K211471Balanced Knee System UniOrtho Development Corporation20210—
+1K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+1K191325EMPOWR Partial KneeEncore Medical L.P.201912
+1K183029MOTO Partial Knee SystemMedacta International S.A.20192—
+1K161741GMK UniMedacta International S.A.20172—
+1K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+1K162084MOTO Partial Knee SystemMedacta International S.A.20173—
+1K161592Persona Partial Knee SystemBiomet, Inc.201652
+1K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+1K123380Stride Unicondylar KneeBlue Belt Technologies, Inc.2013112
+1K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+1K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227—
+1K112301Zimmer Patient Specific Instruments PlannerMaterialise NV20127—
+1K082081Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp.200812—
+1K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.200856—
+1K072704Unicompartmental KneeValpo Orthopedic Technology, Inc.20080—
+1K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200726—
+1K063782Accin Uni-Knee SystemAccin Corporation20074—
+1K060670Accin Uni-Knee SystemAccin Corporation200661
+1K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.2005623
+2K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K251834Persona Partial KneeZimmer Biomet20250—
+2K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+2K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+2K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+2K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+2K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.20201—
+2K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+2K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+2K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+2K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+2K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+2K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+2K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+2K172650Materialise PKA Guide SystemMaterialise NV20176—
+2K171365Arthrex Knee SystemsArthrex, Inc.20170—
+2K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171—
+2K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc.20161—
+2K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163—
+2K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+2K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.2013253
+2K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120—
+2K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201128—
+2K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc.200929—
+2K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation2008512
+2K081351Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200818—
+2K072586Conformis Uni-Condylar Knee SystemConformis, Inc.200730—
+2K072368Conformis Metal Backed Tibial ComponentConformis, Inc.2007313
+2K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc.2007323
+2K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.200643—
+2K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc.200635—
+3K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+3K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+3K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+3K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—
+3K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+3K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+3K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+3K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+3K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+3K173970Materialise PKA Guide SystemMaterialise NV20185—
+3K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+3K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+3K093513Iduo Bicompartmental Knee Repair SystemConformis, Inc.2009173
+3K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation2009505
+3K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+4K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+4K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+4K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+4K202207Materialise PKA Guide SystemMaterialise NV20200—
+4K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+4K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+4K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+4K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+4K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+4K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+4K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+4K122033Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+4K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+4K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+4K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc.201236—
+4K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201138—
+4K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011401
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+5K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+5K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+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—
+5K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—