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KeYi Total Knee System

by Beijing Keyi Medical Device Technology Co., Ltd.

510(k) K230120

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230120 Date19 Apr 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The KeYi Total Knee System is a knee joint patellofemorotibial polymer semi-constrained cemented prosthesis. It is a total knee replacement system designed for orthopedic use.

The device is supplied by Beijing Keyi Medical Device Technology Co., Ltd. and has received FDA 510(k) clearance (K230120) with product code JWH. It was cleared via the traditional pathway on April 19, 2024, following a 458-day review, and is substantially equivalent to a legally marketed predicate device.

Other devices from Beijing Keyi Medical Device Technology Co., Ltd.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the KeYi Total Knee System used for?

    The KeYi Total Knee System is a total knee replacement prosthesis designed for orthopedic use, specifically as a patellofemorotibial polymer semi-constrained cemented device to replace the knee joint in patients requiring arthroplasty.

  • How is the KeYi Total Knee System supplied and is it sterile or single-use?

    The device is supplied by Beijing Keyi Medical Device Technology Co., Ltd. as a prosthesis intended for surgical implantation; while the data does not explicitly state sterility or single-use status, as an implanted orthopedic prosthesis, it is designed for single surgical use and would be provided in a sterile condition for implantation.

  • What regulatory pathway was used for the KeYi Total Knee System and when was it cleared?

    The KeYi Total Knee System received FDA 510(k) clearance through the traditional pathway, with clearance granted on April 19, 2024, following a 458-day review process, and is identified by K-number K230120 and product code JWH.