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Metal-On-Metal Hip Systems-Additional Contraindications

by Biomet Manufacturing, Inc.

510(k) K113271

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)SESE Substantially Equivalent · Traditional NumberK113271 Date18 May 2012ClearedStatusActive

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  • Withdrawn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
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.

This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for total hip arthroplasty. It features cobalt-chromium-molybdenum (Co-Cr-Mo) articulating surfaces, including acetabular cups, femoral heads, adapters, and inserts, intended for uncemented fixation in orthopedic surgery.

The system is supplied as a sterile, single-use orthopedic implant and is regulated under 21 CFR 888.3330 with FDA 510(k) clearance (K113271). It is classified as a Class III device and includes multiple model references for acetabular components. Storage and handling follow standard orthopedic implant protocols to maintain sterility and integrity.

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