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Modification To Restoration Modular System

by Howmedica Osteonics Corp.

510(k) K040734

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK040734 Date25 Aug 2004ClearedStatusActive

Recalls

2 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.

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  • Withdrawn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, 22 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 Modification To Restoration Modular System is a modular hip prosthesis consisting of proximal body styles and distal stem designs that are assembled together. It is classified as a semi-constrained metal/polymer cemented hip prosthesis.

The device is supplied as a system with components including a plasma distal stem made of titanium alloy and hydroxyapatite. It is intended for use in hip revision surgery and is regulated as a Class II device with special controls under FDA 510(k) clearance.

From the manufacturer

This publication sets forth detailed validated procedures for using the Restoration Modular Revision Hip System. ... Howmedica Osteonics Corp. 325 Corporate Drive.

Source: stryker.com

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Restoration Modular System used for?

    The Restoration Modular System is a semi-constrained metal/polymer cemented hip prosthesis intended for use in hip revision surgery. It consists of proximal body styles and distal stem designs that are assembled together to provide a customized solution for patients requiring revision hip procedures.

  • How is the Restoration Modular System supplied?

    The device is supplied as a system with components including a plasma distal stem made of titanium alloy and hydroxyapatite. This modular design allows for various combinations to be used based on the specific surgical requirements of each patient.

  • What is the regulatory classification of the Restoration Modular System?

    The Restoration Modular System is regulated as a Class II device with special controls under FDA 510(k) clearance. It received FDA clearance in 2004 with the K number K040734 and was determined to be substantially equivalent to predicate devices.

  • Is the Restoration Modular System reusable or single-use?

    The device is not explicitly described as single-use or reusable in the provided information. As a surgical implant, it would typically be implanted in the patient and not reused, but the specific handling and disposal instructions would be detailed in the product's instructions for use.