Medical Device Manufacturer · US , Foster City , CA

Conformis, Inc.

60 submissions · 60 cleared · Since 2005
60
Total
60
Cleared
0
Denied

Conformis, Inc. — FDA 510(k) Submissions

Conformis, Inc. has submitted 60 FDA 510(k) premarket notifications since 2005, of which 60 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate . Use the specialty filter in the sidebar to narrow results.

60 devices
1–25 of 60
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
K232426 · MBH Prosthesis, Knee,... · Orthopedic
Sep 2023 28d
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
K223316 · MBH Prosthesis, Knee,... · Orthopedic
Jul 2023 266d
iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
K230846 · JWH Prosthesis, Knee,... · Orthopedic
Jul 2023 111d
Identity? Imprint? CR KRS and Identity? Imprint? PS KRS
K231233 · JWH Prosthesis, Knee,... · Orthopedic
May 2023 28d
ACTERA? hip system
K231178 · MEH Prosthesis, Hip,... · Orthopedic
May 2023 27d
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
K230844 · JWH Prosthesis, Knee,... · Orthopedic
Apr 2023 30d
Actera? hip system
K221104 · MEH Prosthesis, Hip,... · Orthopedic
Aug 2022 112d
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
K221404 · JWH Prosthesis, Knee,... · Orthopedic
Jul 2022 71d
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
K221059 · JWH Prosthesis, Knee,... · Orthopedic
May 2022 29d
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
K213389 · JWH Prosthesis, Knee,... · Orthopedic
Nov 2021 26d
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
K212411 · JWH Prosthesis, Knee,... · Orthopedic
Sep 2021 51d
iTotal? Identity? Cruciate Retaining (CR) Knee Replacement System (KRS)
K210809 · JWH Prosthesis, Knee,... · Orthopedic
May 2021 56d
Identity Imprint Knee Replacement System
K210191 · JWH Prosthesis, Knee,... · Orthopedic
May 2021 101d
Triathlon AS-1
K203421 · OOG Knee Arthroplasty... · Orthopedic
Apr 2021 150d
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
K210252 · JWH Prosthesis, Knee,... · Orthopedic
Feb 2021 19d
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
K203447 · JWH Prosthesis, Knee,... · Orthopedic
Dec 2020 29d
Cordera Hip System
K202484 · LPH Prosthesis, Hip,... · Orthopedic
Sep 2020 24d
iTotal? Identity Posterior Stabilized Knee Replacement System
K201023 · JWH Prosthesis, Knee,... · Orthopedic
Jun 2020 57d
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System
K193105 · JWH Prosthesis, Knee,... · Orthopedic
Mar 2020 126d
Conformis Hip System
K192198 · LPH Prosthesis, Hip,... · Orthopedic
Nov 2019 85d
Conformis BeneFIT Hip System
K190904 · LPH Prosthesis, Hip,... · Orthopedic
Aug 2019 142d
iTotal Identity Cruciate Retaining Knee Replacement System
K190562 · JWH Prosthesis, Knee,... · Orthopedic
Aug 2019 156d
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
K180906 · JWH Prosthesis, Knee,... · Orthopedic
May 2018 40d
iTotal Family Reusable Instrument Tray
K170226 · KCT Sterilization Wrap... · General Hospital
Oct 2017 273d
iTotal? Hip Replacement System
K162719 · LPH Prosthesis, Hip,... · Orthopedic
Jun 2017 258d
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