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Ceramax Ceramic Total Hip System

by Depuy Orthopaedics, Inc.

PMA P070026

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P070026↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP070026 Date23 Dec 2010ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Depuy Ceramax Ceramic Total Hip System
Trade name
Ceramax Ceramic Hip System
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
PMA number
FDA product code
MRA
Device class
Class III
Advisory committee
Orthopedic
FDA decision
APPR Approved

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 Ceramax Ceramic Total Hip System is a semi-constrained hip prosthesis designed for primary total hip replacement. It features a metal/ceramic/ceramic/metal construction, intended for use in skeletally mature patients with degenerative joint disease, including osteoarthritis, avascular necrosis, or post-traumatic arthritis.

This system is supplied in both cemented and uncemented configurations and is approved for noncemented use as indicated by the FDA PMA (P070026). It is intended for use in orthopedic surgical settings and is classified as a Class III medical device. The system includes multiple component sizes and variants, as referenced in the registration and FEI numbers, and is regulated under the Orthopedic advisory committee classification.

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