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Conformis, Inc.

60 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts (K232426)Conformis, Inc.2023-09-08
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (K223316)Conformis, Inc.2023-07-21
iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System (K230846)Conformis, Inc.2023-07-17
Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS (K231233)Conformis, Inc.2023-05-26
ACTERA™ hip system (K231178)Conformis, Inc.2023-05-23
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert (K230844)Conformis, Inc.2023-04-27
Actera™ hip system (K221104)Conformis, Inc.2022-08-04
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (K221404)Conformis, Inc.2022-07-26
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (K221059)Conformis, Inc.2022-05-10
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System (K213389)Conformis, Inc.2021-11-10
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (K212411)Conformis, Inc.2021-09-23
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) (K210809)Conformis, Inc.2021-05-12
Identity Imprint Knee Replacement System (K210191)Conformis, Inc.2021-05-06
Triathlon AS-1 (K203421)Conformis, Inc.2021-04-19
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (K210252)Conformis, Inc.2021-02-17
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement (K203447)Conformis, Inc.2020-12-22
Cordera Hip System (K202484)Conformis, Inc.2020-09-24
iTotal® Identity Posterior Stabilized Knee Replacement System (K201023)Conformis, Inc.2020-06-16
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System (K193105)Conformis, Inc.2020-03-13
Conformis Hip System (K192198)Conformis, Inc.2019-11-06
Conformis BeneFIT Hip System (K190904)Conformis, Inc.2019-08-28
iTotal Identity Cruciate Retaining Knee Replacement System (K190562)Conformis, Inc.2019-08-08
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System (K180906)Conformis, Inc.2018-05-16
iTotal Family Reusable Instrument Tray (K170226)Conformis, Inc.2017-10-25
iTotal® Hip Replacement System (K162719)Conformis, Inc.2017-06-14
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) (K161668)Conformis, Inc.2016-07-15
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) (K161366)Conformis, Inc.2016-06-14
iTotal Cruciate Retaining (CR) Knee Replacement System (K153721)Conformis, Inc.2016-03-25
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System (K160025)Conformis, Inc.2016-03-07
ConforMIS iTotal Posterior Stabilized Knee Replacement System (K153217)Conformis, Inc.2016-01-07
iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System (K152704)Conformis, Inc.2015-10-21
iTotal Posterior Stabilized (PS) Knee Replacement System (K142404)Conformis, Inc.2014-12-11
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM (K142161)Conformis, Inc.2014-11-14
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM (K140833)Conformis, Inc.2014-06-30
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K140423)Conformis, Inc.2014-05-27
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM (K133560)Conformis, Inc.2014-03-28
ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K133256)Conformis, Inc.2014-01-09
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K132640)Conformis, Inc.2013-12-05
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K131467)Conformis, Inc.2013-07-18
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM (K131019)Conformis, Inc.2013-05-24
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122870)Conformis, Inc.2013-01-14
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122991)Conformis, Inc.2012-12-20
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122033)Conformis, Inc.2012-09-27
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K121974)Conformis, Inc.2012-09-06
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K120316)Conformis, Inc.2012-04-19
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K113378)Conformis, Inc.2012-02-15
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) (K120068)Conformis, Inc.2012-02-03
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K112780)Conformis, Inc.2011-12-15
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K111916)Conformis, Inc.2011-09-29
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K103117)Conformis, Inc.2011-01-07
ITOTAL CR KNEE REPLACEMENT SYSTEM (K094050)Conformis, Inc.2010-09-16
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K093513)Conformis, Inc.2009-12-16
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM (K092441)Conformis, Inc.2009-09-09
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS (K080936)Conformis, Inc.2008-05-12
CONFORMIS UNI-CONDYLAR KNEE SYSTEM (K072586)Conformis, Inc.2007-11-08
CONFORMIS METAL BACKED TIBIAL COMPONENT (K072368)Conformis, Inc.2007-09-20
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) (K063432)Conformis, Inc.2007-03-16
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM (K052687)Conformis, Inc.2006-08-31
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (K053488)Conformis, Inc.2006-03-09
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD (K043570)Conformis, Inc.2005-03-14

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Every clearance here is in the API, with alerts when new ones post.