510(k) Report

Devices descending from K911802

66 later devices reach Pmi (Patient Matched Implants) Hip Femoral Comp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033242Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc.200365—
+2K073233Orthoglide Lateral Knee Implant and InstrumentsAdvanced Bio-Surfaces, Inc.20080—
+2K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.200643—
+2K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc.200635—
+2K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062…Advanced Bio-Surfaces, Inc.20061—
+2K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.2005623
+3K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+3K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227—
+3K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201128—
+3K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+3K093513Iduo Bicompartmental Knee Repair SystemConformis, Inc.2009173
+3K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc.200929—
+3K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+3K072586Conformis Uni-Condylar Knee SystemConformis, Inc.200730—
+3K072368Conformis Metal Backed Tibial ComponentConformis, Inc.2007313
+3K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc.2007323
+4K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+4K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+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
+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
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+5K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+5K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+5K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+6K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+6K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+6K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+6K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+6K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+7K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+7K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+7K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+7K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+7K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+7K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+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—
+8K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+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