ConforMIS, Inc.
Wilmington, MA, US
ConforMIS, Inc. appears in FDA device records in Wilmington, MA. FDA records list 60 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 37 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 60FDA records hold 60 510(k) clearances for ConforMIS, Inc. between 2005 and 2023. The busiest year on record is 2012, with 6. The most recent is 2023, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 6 |
| 2013 | 4 |
| 2014 | 6 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 4 |
| 2021 | 6 |
| 2022 | 3 |
| 2023 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | MBH | Substantially Equivalent | |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | MBH | Substantially Equivalent | |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | JWH | Substantially Equivalent | |
| K231233 | Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS | JWH | Substantially Equivalent | |
| K231178 | ACTERA™ hip system | MEH | Substantially Equivalent | |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | JWH | Substantially Equivalent | |
| K221104 | Actera™ hip system | MEH | Substantially Equivalent | |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | JWH | Substantially Equivalent | |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | JWH | Substantially Equivalent | |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | JWH | Substantially Equivalent | |
| K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | JWH | Substantially Equivalent | |
| K210809 | iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) | JWH | Substantially Equivalent | |
| K210191 | Identity Imprint Knee Replacement System | JWH | Substantially Equivalent | |
| K203421 | Triathlon AS-1 | OOG | Substantially Equivalent | |
| K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System | JWH | Substantially Equivalent | |
| K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement | JWH | Substantially Equivalent | |
| K202484 | Cordera Hip System | LPH | Substantially Equivalent | |
| K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | JWH | Substantially Equivalent | |
| K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System | JWH | Substantially Equivalent | |
| K192198 | Conformis Hip System | LPH | Substantially Equivalent | |
| K190904 | Conformis BeneFIT Hip System | LPH | Substantially Equivalent | |
| K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | JWH | Substantially Equivalent | |
| K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | Substantially Equivalent | |
| K170226 | iTotal Family Reusable Instrument Tray | KCT | Substantially Equivalent | |
| K162719 | iTotal® Hip Replacement System | LPH | Substantially Equivalent | |
| K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) | JWH | Substantially Equivalent | |
| K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | JWH | Substantially Equivalent | |
| K153721 | iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | Substantially Equivalent | |
| K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System | JWH | Substantially Equivalent | |
| K153217 | ConforMIS iTotal Posterior Stabilized Knee Replacement System | JWH | Substantially Equivalent | |
| K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System | JWH | Substantially Equivalent | |
| K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System | JWH | Substantially Equivalent | |
| K142161 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K140833 | ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K140423 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K133560 | ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM | JWH | Substantially Equivalent | |
| K133256 | ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | JWH | Substantially Equivalent | |
| K132640 | IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | Substantially Equivalent | |
| K131467 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K131019 | ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K122870 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K122991 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K122033 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K121974 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | Substantially Equivalent | |
| K120316 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K113378 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K120068 | CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) | JWH | Substantially Equivalent | |
| K112780 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent | |
| K111916 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | Substantially Equivalent | |
| K103117 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | JWH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004153240 | 3004153240 | ConforMIS, Inc. | 600 Research Dr, Wilmington, MA 01887 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- OOGKnee Arthroplasty Implantation System
- LXHOrthopedic Manual Surgical Instrument
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Recall records
Showing 25 of 37| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1569-2025 | 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. | Class II | Open, Classified | |
| Z-1591-2024 | Identity Imprint PS Tibial Tray Size 4: Lot 540287 | Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack. | Class II | Open, Classified | |
| Z-2405-2023 | CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO | 30mm screws were labeled as 25mm screws. | Class II | Open, Classified | |
| Z-1133-2023 | iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE | Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure. | Class II | Open, Classified | |
| Z-0899-2022 | iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 | Incorrect tibial base plate implant packaged in kit | Class II | Completed | |
| Z-0475-2021 | 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 stem and single use instrumentation. | Incorrect hip components were provided in kits. | Class II | Terminated | |
| Z-2849-2020 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) | Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920 | Class II | Terminated | |
| Z-1628-2020 | 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 replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. | Class II | Terminated | |
| Z-1627-2020 | 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 replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. | Class II | Terminated | |
| Z-0672-2020 | 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 pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. | Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant. | Class II | Terminated | |
| Z-0064-2020 | iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. | Class II | Terminated | |
| Z-0063-2020 | iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. | Class II | Terminated | |
| Z-1776-2019 | Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT) | Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. | Class II | Terminated | |
| Z-1775-2019 | Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) | Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. | Class II | Terminated | |
| Z-1079-2019 | iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102 | The labeling of the boxes and sterile pouches did not match the contents. | Class II | Terminated | |
| Z-1108-2019 | 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 use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis. | The kits were prepared with incorrect patient ID labels and may contain incorrect components. | Class II | Terminated | |
| Z-0731-2019 | iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 | The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm. | Class II | Terminated | |
| Z-0600-2018 | Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis. | Implant kit mislabeled | Class II | Terminated | |
| Z-0991-2017 | 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 disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis | iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm). | Class II | Terminated | |
| Z-0658-2017 | 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 whose conditions cannot be solely addressed by the use of a prosthetic device. | Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. | Class II | Terminated | |
| Z-1070-2016 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111 | Incorrect femoral component distributed | Class II | Terminated | |
| Z-0148-2016 | ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS) | May contain small amounts of ethylene glycol residue | Class II | Terminated | |
| Z-0147-2016 | ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111 | May contain small amounts of ethylene glycol residue | Class II | Terminated | |
| Z-0146-2016 | ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS) | May contain small amounts of ethylene glycol residue | Class II | Terminated | |
| Z-0145-2016 | ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS) | May contain small amounts of ethylene glycol residue | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain