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Metasul Taper Liners, Metasul Femoral Heads

by Zimmer GmbH

510(k) K091973

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 NumberK091973 Date17 Nov 2009ClearedStatusActive

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0334-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0335-2020 FDA Class II initiated 10 Oct 2019

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

    • Terminated Z-0850-2016 FDA Class II initiated 11 Jan 2016

    LDPE bag containing the implant adheres to the highly polished implant surface.

    • Terminated Z-0071-2014 FDA Class II initiated 30 Aug 2013

    The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

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  • Withdrawn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
KWA
Device Class
Class III
Regulation
21 CFR Part 888.3330
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Metasul Taper Liners and Metasul Femoral Heads are semi-constrained, metal, uncemented acetabular components designed for hip arthroplasty. These components are intended to provide a durable, low-friction articulation for hip joint replacement, utilizing a metal-on-metal bearing surface to enhance longevity and stability in orthopedic applications.

These components are supplied as reusable medical devices and are regulated under FDA 510(k) clearance (K091973) as Class III devices. They are intended for use in orthopedic settings and are manufactured by Zimmer GmbH. The devices are not single-use and must be handled according to sterile processing protocols for surgical implants. No MRI safety information is specified in the provided data.

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