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Modified Profile II Acetabular Cup Prosthesis

by Depuy, Inc. 510(k)

Active United States

510(k) K901087

Overview

This device is an acetabular cup prosthesis, a type of orthopedic implant designed to replace the hip socket in total hip arthroplasty procedures. It is intended to provide a durable articulating surface for the femoral head component of a hip replacement system.

The prosthesis is supplied as a reusable implant and is indicated for use in surgical settings requiring hip joint reconstruction. It received FDA 510(k) clearance under K901087 with product code JDI, and is classified under the Orthopedic advisory committee. No sterility, MRI safety, sizes, and storage conditions are not specified in the provided data.

AI-generated from registry data, 21 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 NumberK901087 Date7 May 1990ClearedStatusActive

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

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Questions

  • What is the Modified Profile II Acetabular Cup Prosthesis used for?

    This device is an acetabular cup prosthesis designed to replace the hip socket in total hip arthroplasty procedures, providing a durable articulating surface for the femoral head component of a hip replacement system.

  • How is the Modified Profile II Acetabular Cup Prosthesis supplied and intended for use?

    The prosthesis is supplied as a reusable implant and is indicated for use in surgical settings requiring hip joint reconstruction, meaning it is intended for multiple uses after appropriate reprocessing.

  • What regulatory pathway was used for the Modified Profile II Acetabular Cup Prosthesis?

    The device received FDA 510(k) clearance under submission number K901087, demonstrating substantial equivalence to a legally marketed predicate device, as indicated by the decision code SESE and decision description 'Substantially Equivalent'.