Conformis Inc.

FDA Regulatory Profile

Summary

Total Recalls
34
510(k) Clearances
60
Inspections
9
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1569-2025Class IIrestor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 AMarch 25, 2025
Z-1591-2024Class IIIdentity Imprint PS Tibial Tray Size 4: Lot 540287March 11, 2024
Z-2405-2023Class IICONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EOJune 16, 2023
Z-1133-2023Class IIiTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AENovember 14, 2022
Z-0899-2022Class IIiTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101February 22, 2022
Z-0475-2021Class IIiTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includesSeptember 21, 2020
Z-2849-2020Class IIConformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1July 20, 2020
Z-1627-2020Class IIiTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFebruary 3, 2020
Z-1628-2020Class IIiTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT)February 3, 2020
Z-0672-2020Class IIiTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR October 25, 2019
Z-0064-2020Class IIiTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem RightAugust 22, 2019
Z-0063-2020Class IIiTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem RightAugust 22, 2019
Z-1775-2019Class IIConformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)March 29, 2019
Z-1776-2019Class IIConformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)March 29, 2019
Z-1079-2019Class IIiTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102January 4, 2019
Z-1108-2019Class IIiTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.December 3, 2018
Z-0731-2019Class IIiTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101October 16, 2018
Z-0600-2018Class IITotal Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- anJuly 24, 2017
Z-0991-2017Class IIConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee ReplacOctober 31, 2016
Z-0658-2017Class IIConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1October 18, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate SacrificSeptember 8, 2023
K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining ToJuly 21, 2023
K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemJuly 17, 2023
K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSMay 26, 2023
K231178ACTERA™ hip systemMay 23, 2023
K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CSApril 27, 2023
K221104Actera™ hip systemAugust 4, 2022
K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS aJuly 26, 2022
K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS aMay 10, 2022
K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior StabNovember 10, 2021
K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS aSeptember 23, 2021
K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)May 12, 2021
K210191Identity Imprint Knee Replacement SystemMay 6, 2021
K203421Triathlon AS-1April 19, 2021
K210252iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior StabiliziFebruary 17, 2021
K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior StabilizinDecember 22, 2020
K202484Cordera Hip SystemSeptember 24, 2020
K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemJune 16, 2020
K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee ReMarch 13, 2020
K192198Conformis Hip SystemNovember 6, 2019