510(k) Report

Devices descending from K012591

90 later devices reach Advance Unicondylar Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100973Evolution Unicondylar Knee SystemWrightmedicaltechnologyinc20100—
+1K090024TGS Unicompartmental Knee Arthroplasty SystemAlexandria Research Technologies, LLC20091—
+1K053299Repicci II Onlay Unicompartmental Tibial ComponentBiomet Manufacturing, Inc.20060—
+1K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc.2004201
+1K022437Uni KneeEncore Medical L.P.2002802
+1K020741Unicondylar KneeEncore Orthopedics, Inc.2002812
+1K014171Advance Unicondylar Knee SystemWrightmedicaltechnologyinc20023—
+2K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171—
+2K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+2K101206TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia SystemAlexandria Research Technologies, LLC20100—
+2K082081Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp.200812—
+2K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.200856—
+2K072368Conformis Metal Backed Tibial ComponentConformis, Inc.2007313
+2K022211HLS Uni Evolution ProsthesisTornier20031—
+3K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+3K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+3K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+3K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+3K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+3K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+3K123380Stride Unicondylar KneeBlue Belt Technologies, Inc.2013112
+3K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227—
+3K120262HLS Uni Evolution & U-KneetecTornier, 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
+3K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+4K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+4K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+4K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+4K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+4K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.2013253
+4K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation2009505
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+5K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163—
+5K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+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—
+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
+6K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+6K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+6K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+6K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.20201—
+6K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+6K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+6K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+6K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+6K171365Arthrex Knee SystemsArthrex, Inc.20170—
+6K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.201525—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+7K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+7K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—
+7K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+7K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+7K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+7K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+7K203421Triathlon AS-1Conformis, Inc.20210—
+7K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+8K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+10K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+10K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+10K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+11K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+11K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301