510(k) Report

Devices descending from K010685

149 later devices reach Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161592Persona Partial Knee SystemBiomet, Inc.201652
+1K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc.200818
+1K072704Unicompartmental KneeValpo Orthopedic Technology, Inc.20080—
+1K033363Zimmer Unicompartmental Knee SystemZimmer, Inc.20041443
+1K022211HLS Uni Evolution ProsthesisTornier20031—
+2K251834Persona Partial KneeZimmer Biomet20250—
+2K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+2K211471Balanced Knee System UniOrtho Development Corporation20210—
+2K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+2K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+2K191325EMPOWR Partial KneeEncore Medical L.P.201912
+2K183029MOTO Partial Knee SystemMedacta International S.A.20192—
+2K161741GMK UniMedacta International S.A.20172—
+2K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+2K162084MOTO Partial Knee SystemMedacta International S.A.20173—
+2K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+2K131167UnivationAesculap Implant Systems, LLC201308
+2K123380Stride Unicondylar KneeBlue Belt Technologies, Inc.2013112
+2K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+2K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227—
+2K120262HLS Uni Evolution & U-KneetecTornier, Inc.20120—
+2K112301Zimmer Patient Specific Instruments PlannerMaterialise NV20127—
+2K082081Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp.200812—
+2K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.200856—
+2K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200726—
+2K063782Accin Uni-Knee SystemAccin Corporation20074—
+2K060670Accin Uni-Knee SystemAccin Corporation200661
+2K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.2005623
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+3K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+3K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+3K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.20201—
+3K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+3K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+3K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+3K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+3K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+3K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+3K172650Materialise PKA Guide SystemMaterialise NV20176—
+3K171365Arthrex Knee SystemsArthrex, Inc.20170—
+3K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171—
+3K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc.20161—
+3K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163—
+3K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+3K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.2013253
+3K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120—
+3K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201128—
+3K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc.200929—
+3K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation2008512
+3K081351Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200818—
+3K072586Conformis Uni-Condylar Knee SystemConformis, Inc.200730—
+3K072368Conformis Metal Backed Tibial ComponentConformis, Inc.2007313
+3K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc.2007323
+3K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.200643—
+3K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc.200635—
+4K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+4K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—
+4K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+4K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+4K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+4K173970Materialise PKA Guide SystemMaterialise NV20185—
+4K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+4K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+4K093513Iduo Bicompartmental Knee Repair SystemConformis, Inc.2009173
+4K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation2009505
+4K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+5K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+5K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+5K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K202207Materialise PKA Guide SystemMaterialise NV20200—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+5K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+5K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+5K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+5K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+5K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+5K122033Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+5K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+5K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+5K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc.201236—
+5K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201138—
+5K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011401
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+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—
+6K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+6K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+6K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+6K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—