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Osteonics Acetabular Wedge System

by Osteonics Corp.

510(k) K971422

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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)SN Traditional NumberK971422 Date22 May 1997DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
SN

Overview

AI-generated summary, 19 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 Osteonics Acetabular Wedge System is a prosthetic device classified under orthopedic implants, designed as an accessory component for total hip replacement procedures. It serves as an alternative to structural allografting in cases involving segmental acetabular defects, providing structural support within the acetabulum to restore anatomical integrity and function.

This system is intended for use in orthopedic surgery settings and is supplied as a reusable or single-use component, depending on institutional protocols. The device is regulated under FDA 510(k) clearance (K971422) with a classification under product code MEH, approved for substantially equivalent indications in 1997. Sterility and MRI safety specifications are not detailed in the provided data.

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