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Depuy Hip Prosthesis

by Depuy, Inc.

PMA P820024510(k) K914078

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization 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), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK914078 Date7 Jan 1993ClearedStatusActive
United StatesFDA PMA PMA 1 supplement NumberP820024 Date16 Mar 1984ApprovedStatusActive

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Full name
Prosthesis, Hip, Hemi-Femoral, Metal
Generic Name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented
PMA Number
510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
PMA Supplement
S005

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.

The Depuy Hip Prosthesis is a hemi-femoral metal device designed for orthopedic use. It functions as a semi-constrained hip replacement component constructed from metal and ceramic materials.

This prosthesis is intended for cemented fixation within the hip joint. The device is manufactured by Depuy, Inc. and is subject to regulatory oversight under FDA 510(k) and PMA authorizations.

Other devices from Depuy, Inc.

See all devices from Depuy, Inc. →

Questions

AI-generated answers, 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.

  • What type of device is the Depuy Hip Prosthesis?

    The Depuy Hip Prosthesis is a hemi-femoral, semi-constrained hip implant composed of metal and ceramic materials, designed for orthopedic surgical procedures.

  • How is this hip prosthesis secured in the body?

    This specific device is designed for cemented fixation, meaning it is intended to be secured in place using surgical bone cement during the implantation process.

  • Is the Depuy Hip Prosthesis regulated?

    Yes, this device is regulated through the FDA, holding both 510(k) clearance and PMA authorization, ensuring it meets the necessary standards for its classification.