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Ceramic Transcend Hip Articulation System

by Ceramtec GmbH PMA

Withdrawn United States

PMA P010001

Overview

The Ceramic Transcend Hip Articulation System is a semi-constrained hip prosthesis designed for primary total hip arthroplasty. It features a metal/ceramic/ceramic/metal bearing configuration, available in cemented or uncemented versions, to restore joint function in patients with degenerative joint diseases such as osteoarthritis, avascular necrosis, congenital hip dysplasia, or traumatic arthritis.

This system is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use device. It is classified under FDA device class III and has received FDA Premarket Approval (PMA P010001). The system includes multiple component sizes and configurations, as referenced by the associated FEI and registration numbers, and must be handled according to sterile surgical protocols.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Withdrawn since 3 Feb 2003. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP010001 Date3 Feb 2003Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

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

United States — FDA PMA Withdrawn

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Full name
Transcend Hip Articulation System
Trade Name
Ceramic Transcend Hip Articulation 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
APWD Approval withdrawn