Skip to content

Metal Transcend Articulation System

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K004043

Overview

The Metal Transcend Articulation System is a semi-constrained metal cemented acetabular component for total hip arthroplasty, designed to restore hip function and alleviate pain in skeletally mature patients. It is classified as a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) under FDA nomenclature.

This device is intended for use in orthopedic surgical settings and is supplied as a reusable system. It is regulated under FDA 510(k) clearance (K004043) and falls under regulation number 888.3320. The system includes multiple component sizes, as referenced by the listed FEI numbers, and is intended for use in procedures involving degenerative joint conditions such as osteoarthritis or avascular necrosis.

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

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK004043 Date13 Jul 2001ClearedStatusActive

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 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JDL
Device Class
Class III
Regulation
21 CFR Part 888.3320
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Wrightmedicaltechnologyinc

See all devices from Wrightmedicaltechnologyinc →

Questions

  • What types of patients is the Metal Transcend Articulation System designed for?

    The Metal Transcend Articulation System is specifically designed for skeletally mature patients undergoing total hip arthroplasty to restore hip function and relieve pain caused by degenerative joint conditions. These conditions include osteoarthritis or avascular necrosis, which are common in older adults or those with joint deterioration.

  • Is the Metal Transcend Articulation System reusable or single-use?

    The Metal Transcend Articulation System is supplied as a reusable system, meaning it is intended for multiple uses in orthopedic surgical settings after proper cleaning and sterilization between procedures.

  • How many component sizes are available for the Metal Transcend Articulation System, and how are they identified?

    The system includes multiple component sizes, each identified by unique FEI numbers. These numbers (e.g., 3020282716, 3007923096) are used to differentiate the specific acetabular components within the Metal Transcend Articulation System, ensuring compatibility with various patient anatomies.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The Metal Transcend Articulation System received FDA clearance through the 510(k) pathway, specifically under the classification of Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). The clearance was granted on July 13, 2001, with the decision described as 'Substantially Equivalent' to a predicate device, and it falls under regulation number 888.3320.