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A3 Total Knee System

by Beijing AK Medical Co., Ltd. China 510(k)

510(k) K180493 Product code JWH

Overview

The A3 Total Knee System is a total knee prosthesis designed for primary knee replacement surgery. It is a substantially equivalent device cleared through the FDA 510(k) process under product code JWH.

The system is manufactured by Beijing AK Medical Co., Ltd. and was cleared via a traditional 510(k) submission (K180493) on June 22, 2018. It is intended for use in orthopedic procedures and is supplied as a non-sterile, reusable implant system requiring sterilization prior to use.

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180493 Date22 Jun 2018ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

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

From the manufacturer

Products & Technology -. AK Medical Standardized products A3 Primary Total Knee System A3 knee prosthesis is suitable for primary knee replacement surgery.

Source: ak-medical.net

Other devices from Beijing AK Medical Co., Ltd.

Questions

  • What is the A3 Total Knee System used for?

    The A3 Total Knee System is designed for primary knee replacement surgery, serving as a total knee prosthesis intended for use in orthopedic procedures to replace damaged knee joints.

  • How is the A3 Total Knee System supplied and prepared for use?

    The system is supplied as a non-sterile, reusable implant system, meaning it must be sterilized by the healthcare provider prior to surgical use to ensure patient safety.

  • What regulatory pathway was used for the A3 Total Knee System?

    The A3 Total Knee System was cleared through the FDA 510(k) process as a substantially equivalent device, with clearance granted under traditional 510(k) submission K180493 on June 22, 2018.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K180493 24 fields · synced 22 Oct 2026