Company · US
Conformis, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2023. Name variants (Inc, Corp, punctuation) are merged.
60510(k) clearances (0 in 12 months)
37recalls (0 in 12 months)
35recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 59 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 11 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 11 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 5 |
| OOG | Knee Arthroplasty Implantation System | 4 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | 1 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2023 | K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts Conformis, Inc. | MBH |
| Jul 21, 2023 | K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement Conformis, Inc. | MBH |
| Jul 17, 2023 | K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System Conformis, Inc. | JWH |
| May 26, 2023 | K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS Conformis, Inc. | JWH |
| May 23, 2023 | K231178 | ACTERA hip system Conformis, Inc. | MEH |
| Apr 27, 2023 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert Conformis, Inc. | JWH |
| Aug 4, 2022 | K221104 | Actera hip system Conformis, Inc. | MEH |
| Jul 26, 2022 | K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Conformis, Inc. | JWH |
| May 10, 2022 | K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Conformis, Inc. | JWH |
| Nov 10, 2021 | K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Rep Conformis, Inc. | JWH |
| Sep 23, 2021 | K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Conformis, Inc. | JWH |
| May 12, 2021 | K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) Conformis, Inc. | JWH |
| May 6, 2021 | K210191 | Identity Imprint Knee Replacement System Conformis, Inc. | JWH |
| Apr 19, 2021 | K203421 | Triathlon AS-1 Conformis, Inc. | OOG |
| Feb 17, 2021 | K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replace Conformis, Inc. | JWH |
| Dec 22, 2020 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Re Conformis, Inc. | JWH |
| Sep 24, 2020 | K202484 | Cordera Hip System Conformis, Inc. | LPH |
| Jun 16, 2020 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System Conformis, Inc. | JWH |
| Mar 13, 2020 | K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iT Conformis, Inc. | JWH |
| Nov 6, 2019 | K192198 | Conformis Hip System Conformis, Inc. | LPH |
| Aug 28, 2019 | K190904 | Conformis BeneFIT Hip System Conformis, Inc. | LPH |
| Aug 8, 2019 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System Conformis, Inc. | JWH |
| May 16, 2018 | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc. | JWH |
| Oct 25, 2017 | K170226 | iTotal Family Reusable Instrument Tray Conformis, Inc. | KCT |
| Jun 14, 2017 | K162719 | iTotal® Hip Replacement System Conformis, Inc. | LPH |
| Jul 15, 2016 | K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) Conformis, Inc. | JWH |
| Jun 14, 2016 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) Conformis, Inc. | JWH |
| Mar 25, 2016 | K153721 | iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc. | JWH |
| Mar 7, 2016 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc. | JWH |
| Jan 7, 2016 | K153217 | ConforMIS iTotal Posterior Stabilized Knee Replacement System Conformis, Inc. | JWH |
| Oct 21, 2015 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System Conformis, Inc. | JWH |
| Dec 11, 2014 | K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System Conformis, Inc. | JWH |
| Nov 14, 2014 | K142161 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Jun 30, 2014 | K140833 | ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| May 27, 2014 | K140423 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Mar 28, 2014 | K133560 | ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM Conformis, Inc. | JWH |
| Jan 9, 2014 | K133256 | ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM Conformis, Inc. | JWH |
| Dec 5, 2013 | K132640 | IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM Conformis, Inc. | HSX |
| Jul 18, 2013 | K131467 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| May 24, 2013 | K131019 | ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Jan 14, 2013 | K122870 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Dec 20, 2012 | K122991 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Sep 27, 2012 | K122033 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Sep 6, 2012 | K121974 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM Conformis, Inc. | HSX |
| Apr 19, 2012 | K120316 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Feb 15, 2012 | K113378 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Feb 3, 2012 | K120068 | CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) Conformis, Inc. | JWH |
| Dec 15, 2011 | K112780 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Sep 29, 2011 | K111916 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM Conformis, Inc. | HSX |
| Jan 7, 2011 | K103117 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
Newest 50 of 60.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2025 | Conformis Inc. restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101
Acetabular Liner for Cordera Hip System Open, Classified |
LPH | K202484 |
| Apr 17, 2024 | Conformis, Inc. Identity Imprint PS Tibial Tray Size 4: Lot 540287 Open, Classified |
JWH | K210191 K231233 |
| Aug 16, 2023 | Conformis, Inc. CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO Open, Classified |
OQG | K190904 K202484 +1 |
| Feb 13, 2023 | Conformis, Inc. iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE Open, Classified |
OIY | None listed |
| Feb 22, 2022 | Conformis, Inc. iTotal Identity Posterior Stabilised (PS) Knee Replacement System
Model Number: TPS-301-1113-020101 Completed |
JWH | K210809 |
| Sep 21, 2020 | Conformis, Inc. iTotal Hip Replacement System, Model number HAA-050-D020-020102
The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral ste Terminated |
LPH | K192198 |
| Jul 20, 2020 | Conformis, Inc. Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant
Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) Terminated |
JWH | K180906 |
| Feb 3, 2020 | Conformis, Inc. iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacemen Terminated |
JWH | K161668 |
| Feb 3, 2020 | Conformis, Inc. iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee repla Terminated |
JWH | K180906 |
| Oct 25, 2019 | Conformis, Inc. iTotal CR Knee Replacement System
Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint p Terminated |
JWH | K180906 |
| Aug 22, 2019 | Conformis, Inc. iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right Terminated |
LPH | K162719 |
| Aug 22, 2019 | Conformis, Inc. iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right Terminated |
LPH | K162719 |
| Mar 29, 2019 | Conformis, Inc. Conformis iTotal Hip Replacement System:
HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT) Terminated |
LPH | None listed |
| Mar 29, 2019 | Conformis, Inc. Conformis iTotal Hip Replacement System:
HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) Terminated |
LPH | K162719 |
| Jan 4, 2019 | Conformis, Inc. iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102 Terminated |
JWH | K161668 |
| Dec 3, 2018 | Conformis, Inc. iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.)
M5725INT0600010 (Model No.)
Product Usage:
The iTotal CR Knee Replacement System is intended for Terminated |
JWH | K180906 |
| Oct 16, 2018 | Conformis, Inc. iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 Terminated |
LPH | K162719 |
| Jul 24, 2017 | ConforMIS, Inc. Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/
Intended for use as a total knee replacement in patients wi Terminated |
JWH | K161668 |
| Jan 10, 2017 | ConforMIS, Inc. ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT
Catalog Number:TPS-111-1111
The iTotal PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disab Terminated |
JWH | K161668 |
| Oct 18, 2016 | ConforMIS, Inc. ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile
Catalog Number: TCR-111-1111.
Intended for use as a total knee replacement in patients with knee joint pain and disability wh Terminated |
JWH | K160025 |
| Jan 28, 2016 | ConforMIS, Inc. Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Model: TCR-111-1111 Terminated |
JWH | K142161 |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iDUO G2, Right Lateral
Catalog Number: M5723INT0600240 (US)
M5723INT0600240 (OUS) Terminated |
NPJ | K093513 K133256 |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iTotal Posterior Stabilized Knee Replacement System-
ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and
ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT
Catalog Number:TPS1111111 Terminated |
JWH | K142161 K142404 |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iTotal CR Knee Replacement System-
iTOTAL CR, Right Knee
Catalog Number: M57250600020 (US)
M5725INT0600020 (OUS) Terminated |
JWH | K142161 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee
Catalog Number: M57250600010 (US)
M5725INT0600010 (OUS) Terminated |
JWH | K142161 |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iTotal CR Knee Replacement System-
ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT
ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT
Catalog Number: TCR1111111 Terminated |
JWH | K142161 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial
Catalog Number: M57230600220 (US)
M5723INT0600220 (OUS) Terminated |
NPJ | K093513 K133256 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral
Catalog Number: M57230600230 Terminated |
NPJ | K093513 K133256 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iUni Unicondylar Knee Replacement System-
iUNI G2, Right Medial
Catalog Number:M57220600220 (US)
M5722INT0600220 (OUS) Terminated |
JWH | K142161 K142404 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iUNI Unicondylar Knee Replacement System
iUNI G2, Right Lateral
Catalog Number: M57220600240 (US)
M5722INT0600240 (OUS) Terminated |
OOG | K132640 K133256 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS Unicondylar Knee Replacement System
iUNI G2, Left Medial
Catalog Number: M57220600210(US)
M5722INT0600210 (OUS) Terminated |
OOG | K132640 K133256 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iUni Unicondylar Knee Replacement System:
iUNI G2, Left Lateral
Catalog Number: M57220600230 (US)
M5722INT0600230 (OUS) Terminated |
OOG | K132640 K133256 |
| Dec 11, 2014 | ConforMIS, Inc. Conformis iTotal CR G2 Knee Replacement System
Catalog/Model #: M57250600010
Intended for use as a total knee replacement in patients with knee joint pain and disability. Terminated |
JWH | K140423 |
| Aug 17, 2012 | Conformis Inc Conformis iTotal CR-Cruciate Retaining Knee Replacement System
Model Numbers:
M57250600010 iTotal CR, Left Knee
M57250600020 iTotal CR, Right Knee
Product Usage : Usage:
The iTotal CR Knee Replac Terminated |
JWH | K103117 |
| Jul 15, 2009 | Conformis Inc ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040.
For cemented use only. System consists of femoral and tibial components. The femoral component is Terminated |
HSX | K043570 K063432 +1 |
| Jul 15, 2009 | Conformis Inc ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020.
For cemented use only. System consists of femoral and tibial components. The femoral component Terminated |
HSX | K043570 K063432 +1 |
| Jul 15, 2009 | Conformis Inc ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010.
For cemented use only. System consists of femoral and tibial components. The femoral component is C Terminated |
HSX | K043570 K063432 +1 |