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Press-Fit Head Resurfacing Device

by Biomet Orthopedics, Inc.

510(k) K023188

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023188 Date11 Dec 2002ClearedStatusActive

Official records

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  • Withdrawn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
KXA
Device class
Class II
Regulation
21 CFR Part 888.3400
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

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 Press-Fit Head Resurfacing Device is a Prosthesis, Hip, Femoral, Resurfacing, designed to replace the outer surface of the femoral head while preserving bone stock. It is intended for use in hip arthroplasty procedures, offering a press-fit application to secure the resurfacing component within the femoral head.

This device is supplied as a single-use implant and is classified as a Class 2 medical device under FDA regulations. It is intended for surgical use in orthopedic settings and requires sterile conditions for implantation. The device’s design is substantively equivalent to its predicate, adhering to FDA clearance (K023188) granted under the 510(k) pathway in 2002.

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