Conformis Inc.
FDA Regulatory Profile
Conformis Inc. appears in FDA public data with 34 recalls, 60 510(k) clearances, 9 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1569-2025, Class II) was initiated on March 25, 2025. Its most recent 510(k) clearance was granted on September 8, 2023.
Summary
- Total Recalls
- 34
- 510(k) Clearances
- 60
- Inspections
- 9
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1569-2025 | Class II | restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 A | March 25, 2025 |
| Z-1591-2024 | Class II | Identity Imprint PS Tibial Tray Size 4: Lot 540287 | March 11, 2024 |
| Z-2405-2023 | Class II | CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO | June 16, 2023 |
| Z-1133-2023 | Class II | iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE | November 14, 2022 |
| Z-0899-2022 | Class II | iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 | February 22, 2022 |
| Z-0475-2021 | Class II | iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes | September 21, 2020 |
| Z-2849-2020 | Class II | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1 | July 20, 2020 |
| Z-1628-2020 | Class II | iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) | February 3, 2020 |
| Z-1627-2020 | Class II | iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LE | February 3, 2020 |
| Z-0672-2020 | Class II | iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR | October 25, 2019 |
| Z-0064-2020 | Class II | iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right | August 22, 2019 |
| Z-0063-2020 | Class II | iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right | August 22, 2019 |
| Z-1775-2019 | Class II | Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) | March 29, 2019 |
| Z-1776-2019 | Class II | Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT) | March 29, 2019 |
| Z-1079-2019 | Class II | iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102 | January 4, 2019 |
| Z-1108-2019 | Class II | iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No. | December 3, 2018 |
| Z-0731-2019 | Class II | iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 | October 16, 2018 |
| Z-0600-2018 | Class II | Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- an | July 24, 2017 |
| Z-0991-2017 | Class II | ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replac | October 31, 2016 |
| Z-0658-2017 | Class II | ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1 | October 18, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrific | September 8, 2023 |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining To | July 21, 2023 |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | July 17, 2023 |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS | May 26, 2023 |
| K231178 | ACTERA hip system | May 23, 2023 |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS | April 27, 2023 |
| K221104 | Actera hip system | August 4, 2022 |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS a | July 26, 2022 |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS a | May 10, 2022 |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stab | November 10, 2021 |
| K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS a | September 23, 2021 |
| K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) | May 12, 2021 |
| K210191 | Identity Imprint Knee Replacement System | May 6, 2021 |
| K203421 | Triathlon AS-1 | April 19, 2021 |
| K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizi | February 17, 2021 |
| K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizin | December 22, 2020 |
| K202484 | Cordera Hip System | September 24, 2020 |
| K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | June 16, 2020 |
| K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Re | March 13, 2020 |
| K192198 | Conformis Hip System | November 6, 2019 |