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Procotyl-E Acetabular System

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K043073

Overview

The Procotyl-E Acetabular System is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). It is designed as an acetabular cup component for use in total hip arthroplasty, providing structural support for the hip joint to restore function and alleviate pain in skeletally mature patients.

This device is intended for single-use in orthopedic surgical settings and is classified as a Class III medical device under FDA regulations. It is supplied sterile and requires proper handling and storage as per manufacturer guidelines. The system is regulated under FDA 510(k) clearance (K043073) and adheres to the regulatory requirements outlined in 21 CFR 888.3330.

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 · Traditional NumberK043073 Date4 May 2005ClearedStatusActive

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

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0183-2013 FDA Class II initiated 5 Sep 2012 via K043073, on the same 510(k)
    • Terminated Z-0185-2013 FDA Class II initiated 5 Sep 2012 via K043073, on the same 510(k)
    • Terminated Z-0184-2013 FDA Class II initiated 5 Sep 2012 via K043073, on the same 510(k)

    There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
KWA
Device Class
Class III
Regulation
21 CFR Part 888.3330
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Procotyl-E Acetabular System used for in clinical practice?

    The Procotyl-E Acetabular System is designed as a semi-constrained metal uncemented acetabular cup for use in total hip arthroplasty. It provides structural support to the hip joint, helping to restore function and relieve pain in skeletally mature patients undergoing hip replacement surgery.

  • Is the Procotyl-E Acetabular System intended for reuse or single-use in the operating room?

    The Procotyl-E Acetabular System is explicitly intended for single-use in orthopedic surgical settings. This design ensures patient safety and sterility, requiring proper handling and adherence to manufacturer guidelines to maintain its sterile condition.

  • How is the Procotyl-E Acetabular System supplied, and what storage precautions should be taken?

    The system is supplied sterile and must be handled and stored according to the manufacturer’s guidelines to preserve sterility. Since it is single-use, it should be stored in a clean, dry environment, protected from contamination until use, and discarded after a single surgical procedure.

  • What regulatory pathway does the Procotyl-E Acetabular System follow, and how is it classified?

    The Procotyl-E Acetabular System is classified as a Class III medical device under FDA regulations and has received FDA 510(k) clearance (K043073). It is regulated under 21 CFR 888.3330, with a decision of Substantially Equivalent (SESE) by the Orthopedic (OR) Advisory Committee.