Data / Medical devices / United States / ConforMIS, Inc.
ConforMIS, Inc.: FDA-registered device maker in Wilmington, MA, United States, 37 510(k) clearances
ConforMIS, Inc. is registered with the FDA (registration 3004153240) in Wilmington, MA, United States. It lists 12 device types. The FDA files 37 510(k) clearances under its listings, the newest dated December 5, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004153240
- Address
- 600 Research Dr, Wilmington, MA, United States, 01887
- Owner or operator
- restor3d, Inc. (9058483)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- March 6, 2007
- Registered through
- 2026
- Brand names listed
- 3.5MM Hex U-Joint Driver, ACTERA (femoral stems sizes 0,1,10,11,12 and patient specific neck sizes 0-12), ACTERA Broaches 0,1,10,11,12, ACTERA Trial Necks, ANGEL WING RESECTION GUIDE, Acetabular Cup Impactor, Acetabular reamer handle and sleeve, Actera Trial Necks single Use and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 5, 2025 | K252067 | Velora Acetabular System | LPH | Substantially Equivalent | Restor3D, Inc. | accessdata.fda.gov |
| March 27, 2025 | K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | MBH | Substantially Equivalent | Restor3D, Inc. | accessdata.fda.gov |
| July 21, 2023 | K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | MBH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| May 23, 2023 | K231178 | ACTERA hip system | MEH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| April 27, 2023 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| May 12, 2021 | K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| May 6, 2021 | K210191 | Identity Imprint Knee Replacement System | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| April 19, 2021 | K203421 | Triathlon AS-1 | OOG | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| September 24, 2020 | K202484 | Cordera Hip System | LPH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| June 16, 2020 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| March 13, 2020 | K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| November 6, 2019 | K192198 | Conformis Hip System | LPH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| August 28, 2019 | K190904 | Conformis BeneFIT Hip System | LPH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| August 8, 2019 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| October 25, 2017 | K170226 | iTotal Family Reusable Instrument Tray | KCT | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| June 14, 2017 | K162719 | iTotal® Hip Replacement System | LPH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| July 15, 2016 | K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| June 14, 2016 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| March 25, 2016 | K153721 | iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| March 7, 2016 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| December 11, 2014 | K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| November 14, 2014 | K142161 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| June 30, 2014 | K140833 | ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| May 27, 2014 | K140423 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| March 28, 2014 | K133560 | ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| January 9, 2014 | K133256 | ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| December 5, 2013 | K132640 | IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| September 6, 2012 | K121974 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| April 19, 2012 | K120316 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| February 3, 2012 | K120068 | CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) | JWH | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| September 29, 2011 | K111916 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| December 16, 2009 | K093513 | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | NPJ | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| September 9, 2009 | K092441 | MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM | HSX | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| November 8, 2007 | K072586 | CONFORMIS UNI-CONDYLAR KNEE SYSTEM | HSX | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| March 9, 2006 | K053488 | CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM | NPJ | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| March 14, 2005 | K043570 | UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD | HSX | Substantially Equivalent | Conformis, Inc. | accessdata.fda.gov |
| October 29, 2003 | K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | KCT | Substantially Equivalent | Paragon Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 25, 2025 | 96606 | Class II | Ongoing | restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System | The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner. | accessdata.fda.gov |
| July 17, 2012 | 62576 | Class II | Terminated | 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 Replacement System (KRS) is int | Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique | accessdata.fda.gov |
| April 23, 2009 | 51903 | Not yet classified | Terminated | 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 CoCrMo personalized on its | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of Knee Arthroplasty Implantation System
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Updated December 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.