510(k) Report

Devices descending from K954481

60 later devices reach P.F.C. Uni-Compartmental Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040268Depuy Preservation Unicondylar TibiaDePuy Orthopaedics, Inc.20044710
+1K982859UC-Plus Solution Unicondylar Knee SystemPlus Orthopedics1999251
+2K101206TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia SystemAlexandria Research Technologies, LLC20100—
+2K072368Conformis Metal Backed Tibial ComponentConformis, Inc.2007313
+2K070267Depuy GCK Tibial ComponentsDePuy Orthopaedics, Inc.200712—
+2K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc.2007323
+2K050764Uniglide Unicondylar Knee ProsthesisCorin USA20052—
+2K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc.2004201
+2K032052UC-Plus Solution Unicondylar KneePlus Orthopedics200301
+3K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+3K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC20200—
+3K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171—
+3K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+3K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227—
+3K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201128—
+3K093056Smith & Nephew, Inc. Journey Select Knee SystemSmith & Nephew, Inc.20099—
+3K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc.200929—
+3K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+4K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+4K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+4K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+4K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+4K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+4K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+4K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+4K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.2013253
+5K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+5K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+5K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+5K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+6K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+7K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+7K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+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—
+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