510(k) Report

Devices descending from K954186

55 later devices reach Sled Unicompartment Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG2016916
+1K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc.2007323
+1K050373Unicap Unicompartmental Knee Resurfacing ProsthesisArthrosurface, Inc.20052—
+1K050764Uniglide Unicondylar Knee ProsthesisCorin USA20052—
+1K042093Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc.200462
+1K022211HLS Uni Evolution ProsthesisTornier20031—
+2K221292Uni Knee Resurfacing SystemOverture Resurfacing, Inc.20231—
+2K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+2K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG2021122
+2K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG20210—
+2K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+2K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+2K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171—
+2K122277Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford…Biomet Manufacturing Corp2012230
+2K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227—
+2K120262HLS Uni Evolution & U-KneetecTornier, Inc.20120—
+2K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201128—
+2K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc.200929—
+2K072368Conformis Metal Backed Tibial ComponentConformis, Inc.2007313
+3K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+3K242746OvertureTi Knee Resurfacing SystemTMOverture Orthopaedics20240—
+3K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+3K211664GMK Sphere RevisionMedacta International S.A.20210—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+3K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd.201414
+3K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+3K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.2013253
+3K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+4K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+4K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+4K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+5K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+5K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+5K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+6K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+6K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+7K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+10K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+10K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301