Conformis, Inc.
Conformis, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2023, with 34 FDA device recalls on record.
Top product codes for Conformis, Inc.
FDA recalls by Conformis, Inc.
10 most recent of 34- 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
- Z-1591-2024 — Identity Imprint PS Tibial Tray Size 4: Lot 540287
- Z-2405-2023 — CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
- Z-1133-2023 — iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
- Z-0899-2022 — iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
- 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.
- 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)
- 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.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Conformis, Inc.
- K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
- K223316 — Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
- K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
- K231233 — Identity Imprint CR KRS and Identity Imprint PS KRS
- K231178 — ACTERA hip system
- K230844 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
- K221104 — Actera hip system
- K221404 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
- K221059 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
- K213389 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
- K212411 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
- K210809 — iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS)
- K210191 — Identity Imprint Knee Replacement System
- K203421 — Triathlon AS-1
- K210252 — iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
- K203447 — iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
- K202484 — Cordera Hip System
- K201023 — iTotal® Identity Posterior Stabilized Knee Replacement System
- K193105 — iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System
- K192198 — Conformis Hip System
- K190904 — Conformis BeneFIT Hip System
- K190562 — iTotal Identity Cruciate Retaining Knee Replacement System
- K180906 — Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
- K170226 — iTotal Family Reusable Instrument Tray
- K162719 — iTotal® Hip Replacement System
- K161668 — ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
- K161366 — ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
- K153721 — iTotal Cruciate Retaining (CR) Knee Replacement System
- K160025 — iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
- K153217 — ConforMIS iTotal Posterior Stabilized Knee Replacement System
- K152704 — iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System
- K142404 — iTotal Posterior Stabilized (PS) Knee Replacement System
- K142161 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
- K140833 — ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
- K140423 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K133560 — ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
- K133256 — ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
- K132640 — IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
- K131467 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K131019 — ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM
- K122870 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K122991 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K122033 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K121974 — CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
- K120316 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K113378 — CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K120068 — CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)
- K112780 — CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K111916 — CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
- K103117 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K094050 — ITOTAL CR KNEE REPLACEMENT SYSTEM
- K093513 — IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
- K092441 — MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM
- K080936 — CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
- K072586 — CONFORMIS UNI-CONDYLAR KNEE SYSTEM
- K072368 — CONFORMIS METAL BACKED TIBIAL COMPONENT
- K063432 — CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)
- K052687 — CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM
- K053488 — CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM
- K043570 — UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
Data sourced from openFDA. This site is unofficial and independent of the FDA.