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Amk Landmark Revision Knee System

by Depuy, Inc. 510(k)

Active United States

510(k) K925072

Overview

The Amk Landmark Revision Knee System is a knee prosthesis, classified as a semi-constrained, cemented, polymer/metal/polymer device. It is used in orthopedic procedures. The device has a product code of JWH.

The Amk Landmark Revision Knee System is supplied by Depuy, Inc. and has been assigned the k number K925072. It was found to be substantially equivalent and was cleared on January 21, 1994. The device is classified as Class II and is subject to special controls.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925072 Date21 Jan 1994ClearedStatusActive

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Amk Landmark Revision Knee System used for?

    The Amk Landmark Revision Knee System is used in orthopedic procedures as a knee prosthesis, providing a semi-constrained, cemented solution.

  • How is the Amk Landmark Revision Knee System supplied?

    The device is supplied by Depuy, Inc. and has been assigned the k number K925072, indicating its clearance and regulatory status.

  • Is the Amk Landmark Revision Knee System a single-use or reusable device?

    The device is classified as a polymer/metal/polymer device, but its single-use or reusable status is not explicitly stated, suggesting it may be intended for single-use due to its cemented nature.

  • What are the regulatory classifications of the Amk Landmark Revision Knee System?

    The device is classified as Class II, subject to special controls, with a product code of JWH and an advisory committee description of Orthopedic.