510(k) Report

Devices descending from K021740

52 later devices reach Total Knee Cemented, Semi-Constrained through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160159Active-X Total Knee SystemSignature Orthopaedics Pty, Ltd.20166—
+1K093567Active Knee Total Knee Replacement SystemAnova Implant Solutions, LLC20100—
+1K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.200643—
+2K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd.20195—
+2K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+2K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+3K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Signature Orthopaedics Pty, Ltd.20224—
+3K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+3K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+3K122033Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+3K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+3K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+3K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc.201236—
+3K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201138—
+3K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011401
+4K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+4K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+4K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+4K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+4K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+4K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+5K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+5K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+5K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+5K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+6K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+6K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+6K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+6K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+7K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+7K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+7K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+7K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+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