FDA 510(k) Applications Submitted by ConforMIS, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160025 |
01/06/2016 |
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System |
CONFORMIS, INC. |
| K120068 |
01/09/2012 |
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) |
CONFORMIS, INC. |
| K140423 |
02/18/2014 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K140833 |
04/02/2014 |
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K131019 |
04/12/2013 |
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K161366 |
05/17/2016 |
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) |
CONFORMIS, INC. |
| K131467 |
05/21/2013 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K161668 |
06/16/2016 |
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) |
CONFORMIS, INC. |
| K142161 |
08/06/2014 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K092441 |
08/10/2009 |
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
| K132640 |
08/23/2013 |
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K122991 |
09/26/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K162719 |
09/29/2016 |
iTotal« Hip Replacement System |
ConforMIS, Inc. |
| K153217 |
11/05/2015 |
ConforMIS iTotal Posterior Stabilized Knee Replacement System |
ConforMIS, Inc. |
| K133560 |
11/20/2013 |
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM |
CONFORMIS, INC. |
| K153721 |
12/28/2015 |
iTotal Cruciate Retaining (CR) Knee Replacement System |
CONFORMIS, INC. |
| K093513 |
11/13/2009 |
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
| K120316 |
02/01/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K121974 |
07/05/2012 |
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K111916 |
07/06/2011 |
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K122033 |
07/11/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K122870 |
09/19/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K112780 |
09/26/2011 |
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K103117 |
10/21/2010 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K113378 |
11/16/2011 |
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K094050 |
12/31/2009 |
ITOTAL CR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K133256 |
10/23/2013 |
ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
| K180906 |
04/06/2018 |
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System |
Conformis, Inc. |
| K190904 |
04/08/2019 |
Conformis BeneFIT Hip System |
ConforMIS, Inc. |
| K043570 |
12/27/2004 |
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD |
CONFORMIS, INC. |
| K210809 |
03/17/2021 |
iTotal« IdentityÖ Cruciate Retaining (CR) Knee Replacement System (KRS) |
Conformis, Inc. |
| K072368 |
08/23/2007 |
CONFORMIS METAL BACKED TIBIAL COMPONENT |
CONFORMIS, INC. |
| K063432 |
11/13/2006 |
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) |
CONFORMIS, INC. |
| K230846 |
03/28/2023 |
iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System |
Conformis, Inc. |
| K201023 |
04/20/2020 |
iTotal« Identity Posterior Stabilized Knee Replacement System |
Conformis, Inc. |
| K202484 |
08/31/2020 |
Cordera Hip System |
Conformis, Inc. |
| K193105 |
11/08/2019 |
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System |
Conformis, Inc. |
| K231233 |
04/28/2023 |
IdentityÖ ImprintÖ CR KRS and IdentityÖ ImprintÖ PS KRS |
Conformis, Inc. |
| K052687 |
09/28/2005 |
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
| K053488 |
12/15/2005 |
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
| K190562 |
03/05/2019 |
iTotal Identity Cruciate Retaining Knee Replacement System |
Conformis, Inc. |
| K192198 |
08/13/2019 |
Conformis Hip System |
Conformis, Inc. |
| K080936 |
04/02/2008 |
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS |
CONFORMIS, INC. |
| K072586 |
09/13/2007 |
CONFORMIS UNI-CONDYLAR KNEE SYSTEM |
CONFORMIS, INC. |
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