510(k) Report

Devices descending from K063432

32 later devices reach Conformis Metal Backed Tibial Component (MBT) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227—
+1K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201128—
+1K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc.200929—
+1K072368Conformis Metal Backed Tibial ComponentConformis, Inc.2007313
+2K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+2K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.2013253
+2K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+3K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+3K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+4K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+4K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+4K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+4K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+4K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+6K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+9K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301