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Freeman Acetabular Cup

by Depuy, Inc. 510(k)

Active United States

510(k) K832958

Overview

The Freeman Acetabular Cup is a prosthesis for hip replacement, classified as a semi-constrained metal/polymer cemented device. It is designed to replace the acetabulum portion of the hip joint in patients requiring hip arthroplasty.

The device is supplied by Depuy, Inc. and received FDA 510(k) clearance on October 4, 1983 (K832958). It is regulated as a Class II device with special controls. No information regarding sterility, single-use status, MRI safety, or specific sizes is provided in the data.

AI-generated from registry data, 22 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 NumberK832958 Date4 Oct 1983ClearedStatusActive

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 Freeman Acetabular Cup used for?

    The Freeman Acetabular Cup is a prosthesis designed to replace the acetabulum portion of the hip joint in patients requiring hip arthroplasty. It is classified as a semi-constrained metal/polymer cemented device.

  • How is the Freeman Acetabular Cup supplied?

    The device is supplied by Depuy, Inc. The available data does not specify sterility status, single-use or reuse instructions, or specific sizes available for this product.

  • What is the regulatory status of the Freeman Acetabular Cup?

    The Freeman Acetabular Cup received FDA 510(k) clearance on October 4, 1983 (K832958). It is regulated as a Class II device with special controls. The device was determined to be substantially equivalent to predicate devices.

  • What are the specifications of the Freeman Acetabular Cup?

    The Freeman Acetabular Cup is classified as a semi-constrained metal/polymer cemented device for hip replacement. The product code is JDI, and it was reviewed by the Orthopedic advisory committee. No specific measurements or technical specifications are provided in the available data.