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BI-MENTUM dual mobility system

by Serf

510(k) K181744

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181744 Date11 Dec 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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, 27 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 dual mobility system is a dual mobility system for revision hip surgery. It is a total hip prosthesis acetabular component consisting of a metallic shell and a mobile UHMWPE liner. The system features four shell styles and a moderately cross-linked polyethylene liner that articulates within the inner surface of the shell to create natural movement and optimized range of motion.

The BI-MENTUM dual mobility system is used in total hip replacement surgeries. It is supplied as a monoblock dual mobility hip system with a moderately cross-linked polyethylene liner. The system has FDA 510K clearance with the product code LZO and is manufactured by Serf.

Other devices from Serf

Questions

AI-generated answers, 27 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 dual mobility system used for?

    The BI-MENTUM dual mobility system is designed for revision hip surgery as a total hip prosthesis acetabular component. It consists of a metallic shell and a mobile UHMWPE liner that articulates to create natural movement and optimized range of motion.

  • How is the BI-MENTUM dual mobility system supplied?

    The system is supplied as a monoblock dual mobility hip system with a moderately cross-linked polyethylene liner. It is available in four different shell styles to accommodate various surgical needs.

  • What is the regulatory status of the BI-MENTUM dual mobility system?

    The BI-MENTUM dual mobility system has FDA 510K clearance with product code LZO. It received clearance on December 11, 2018, and is manufactured by Serf in Decines, France.

  • What materials are used in the BI-MENTUM dual mobility system?

    The system consists of a metallic shell and a mobile UHMWPE (ultra-high-molecular-weight polyethylene) liner. The liner is moderately cross-linked to provide durability and optimal performance in hip replacement surgeries.