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Synatomic Revision Femoral Prosthesis

by Depuy, Inc. 510(k)

Active United States

510(k) K860594

Overview

This device is a femoral prosthesis used in revision hip arthroplasty procedures. It is designed to replace the femoral component in total hip replacements, particularly in cases requiring revision surgery.

The prosthesis is supplied non-sterile and intended for single use. It is manufactured by Depuy, Inc. and received FDA 510(k) clearance under K860594 with product code JWH. The device is indicated for orthopedic use and was cleared via the traditional 510(k) pathway.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK860594 Date14 Mar 1986DecidedStatusActive

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
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SN

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Questions

  • What is the SYNATOMIC Revision Femoral Prosthesis used for?

    It is used in revision hip arthroplasty procedures to replace the femoral component in total hip replacements, particularly when prior implants have failed or require replacement due to loosening, wear, or infection.

  • How is the SYNATOMIC Revision Femoral Prosthesis supplied and is it reusable?

    The device is supplied non-sterile and is intended for single use only; it must be sterilized by the healthcare provider before implantation and should not be reprocessed or reused after initial use to ensure patient safety and device integrity.

  • What regulatory pathway was used for the SYNATOMIC Revision Femoral Prosthesis and what is its FDA identifier?

    The device received FDA 510(k) clearance through the traditional pathway under submission number K860594, with product code JWH, indicating it was found substantially equivalent to a legally marketed predicate device for certain orthopedic indications.