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Ath Femoral Stem

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K034028

Overview

The ATH FEMORAL STEM is a prosthesis, hip, semi-constrained, metal/polymer, cemented device classified under product code JDI. It is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

The device is supplied by Wrightmedicaltechnologyinc and received FDA 510(k) clearance (K034028) on March 11, 2004, following a determination of substantial equivalence. It is a Class II device subject to special controls and was reviewed by the Orthopedic advisory committee.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK034028 Date11 Mar 2004ClearedStatusActive

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
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Wrightmedicaltechnologyinc

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Questions

  • What is the ATH FEMORAL STEM used for?

    The ATH FEMORAL STEM is indicated for use in total hip arthroplasty to reduce or relieve pain and/or improve hip function in skeletally mature patients. It is a semi-constrained metal/polymer prosthesis designed for cemented fixation in the femur.

  • How is the ATH FEMORAL STEM supplied and is it sterile?

    The device is supplied by Wrightmedicaltechnologyinc as a sterile, single-use implant. It is provided in a sterile package for direct use in surgery and is not intended for reuse after implantation.

  • What regulatory pathway was used for the ATH FEMORAL STEM and when was it cleared?

    The ATH FEMORAL STEM received FDA 510(k) clearance under K034028 on March 11, 2004, following a determination of substantial equivalence. It is classified as a Class II device under product code JDI and is subject to special controls.