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BI-MENTUM ALTRX Dual Mobility Liner

by DePuy Ireland UC

510(k) K203532

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203532 Date28 Apr 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BI-MENTUM ALTRX Dual Mobility Liner is a highly cross-linked UHMWPE acetabular component designed for use in total hip arthroplasty. It functions as a mobile liner within a metallic shell, articulating with a prosthetic femoral head to provide joint stability. The device is intended for single use only.

The liner is supplied sterile and is used in revision hip surgery as part of the BI-MENTUM Dual Mobility System. It is regulated under 21 CFR 888.3353 as a hip joint metal/ceramic/polymer semi-constrained cemented or nonporous device. The device is stored according to standard medical device storage practices and is authorized for use under FDA 510K clearance.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BI-MENTUM ALTRX Dual Mobility Liner used for?

    This liner is used in total hip arthroplasty, specifically in revision hip surgery. It acts as a mobile liner within a metallic shell, articulating with a prosthetic femoral head to provide joint stability and reduce the risk of dislocation.

  • How is the device supplied and what is its sterility status?

    The device is supplied sterile and is intended for single use only. It should be stored according to standard medical device storage practices to maintain its integrity and sterility until the time of implantation.

  • Is this device part of a larger system?

    Yes, the BI-MENTUM ALTRX Dual Mobility Liner is part of the BI-MENTUM Dual Mobility System. It is designed to function within this system, specifically as a mobile liner within a metallic shell, to provide enhanced joint stability during hip replacement procedures.

  • What material is the liner made from?

    The liner is constructed from highly cross-linked Ultra-High-Molecular-Weight Polyethylene (UHMWPE). This material is chosen for its durability and wear resistance, which are critical for the long-term performance of the implant in total hip arthroplasty.