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Restoration ADM System

by Howmedica Osteonics Corp.

510(k) K072020

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK072020 Date18 Oct 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0194-2012 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K072020

    Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
MEH
Device class
Class II
Regulation
21 CFR Part 888.3353
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Restoration ADM System is a semi‑constrained, uncemented hip prosthesis composed of metal and polymer components with a non‑porous calcium phosphate surface. It is classified under product code MEH as a Class II device subject to special controls for prostheses used in total hip arthroplasty.

The system is supplied as a sterile, single‑use device intended for primary and revision total hip arthroplasty and is compatible with currently available Howmedica Osteonics femoral heads of 22.2 mm and 28 mm diameter. It received FDA 510(k) clearance (K072020) on 18 October 2007 and is marketed by Howmedica Osteonics Corp. in Mahwah, New Jersey.

From the manufacturer

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademark(s) or service mark(s): ADM, Howmedica, MDM, Osteonics, Restoration, Stryker, X3.

Source: stryker.com

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