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Restoration Modular System

by Howmedica Osteonics Corp. 2 variants

510(k) K022549

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK022549 Date23 Sep 2002ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2487-2012 FDA Class II initiated 2 Apr 2012

    Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section.

    • Terminated Z-1642-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009

    Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst test results for recalled products fell below the validated parameters.

    • Terminated Z-0884-2009 FDA Unclassified (pre-2012) initiated 21 Nov 2008

    Stryker became aware of a lot for lot mix up.

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  • Withdrawn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

Overview

AI-generated summary, 27 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 Modular System is a two-piece femoral stem designed for use in primary or revision total hip arthroplasty. It is intended to address cases involving severe proximal bone loss by being press-fit into the proximal femur.

This system is designed for use with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. The device has received FDA 510(k) clearance.

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