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Modified Freeman Revision Acetabular Cup

by Turnkey Intergration USA, Inc. 510(k)

Active United States

510(k) K902111

Overview

The Modified Freeman Revision Acetabular Cup is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). This device is designed as a replacement for damaged or diseased acetabular surfaces in the hip joint, providing structural support and facilitating joint mobility through its semi-constrained design.

Intended for surgical revision procedures, this acetabular cup is supplied as a metal, uncemented component and is classified as a Class III medical device under FDA regulations. It is intended for use in orthopedic settings and requires sterile packaging for single-use applications. The device’s design adheres to FDA clearance (510K) and is governed by regulation number 888.3330, ensuring compliance with orthopedic implant standards.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902111 Date22 Aug 1990ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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
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 types of hip surgeries is the Modified Freeman Revision Acetabular Cup designed for, and why is it considered semi-constrained?

    The Modified Freeman Revision Acetabular Cup is specifically designed for surgical revision procedures where the natural acetabular surface of the hip joint is damaged or diseased. Its semi-constrained design provides a balance between stability and mobility, allowing for controlled movement while reducing the risk of dislocation compared to fully unconstrained cups. This makes it ideal for patients who need additional stability after a primary hip replacement has failed or in complex revisions.

  • Is this device reusable, or is it intended for single-use only? How is it packaged to ensure sterility?

    The Modified Freeman Revision Acetabular Cup is intended for single-use only, as indicated by its sterile packaging. This ensures that each device remains uncontaminated and safe for surgical use, reducing the risk of infection or cross-contamination in the operating room.

  • What materials is the Modified Freeman Revision Acetabular Cup made from, and why is it classified as uncemented?

    The device is made from metal, as explicitly stated in its description. It is classified as uncemented, meaning it is designed to be press-fit into the patient’s acetabulum without the use of bone cement. This allows for better bone integration over time, promoting long-term stability and reducing the risk of loosening.

  • How do I verify the regulatory compliance of this device before purchasing or using it?

    The Modified Freeman Revision Acetabular Cup holds an FDA 510(k) clearance (K902111) under regulation number 888.3330, confirming its compliance with U.S. orthopedic implant standards. The device is also governed by the Orthopedic (OR) advisory committee, ensuring it meets the necessary safety and effectiveness criteria for surgical use. Always verify the specific lot or batch registration number (e.g., 8043792) with the manufacturer or regulatory databases to confirm its current status.