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Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner

by Depuy Orthopaedics, Inc.

510(k) K010171

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 NumberK010171 Date6 Apr 2001ClearedStatusActive

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  • Withdrawn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
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
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 Duraloc Acetabular Cup System, 36mm Marathon +4 Polyethylene Liner is a hip prosthesis classified as a semi-constrained metal/polymer device with a porous coating. It consists of an acetabular cup and a polyethylene liner designed for use in hip joint replacement procedures.

This device is supplied non-sterile and intended for single use. It received FDA 510(k) clearance under K010171 on April 6, 2001, and is classified under regulation 888.3358 with product code LPH. The device is manufactured by DePuy Orthopaedics, Inc. and is indicated for hip arthroplasty as a substantially equivalent device to previously cleared products.

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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 Duraloc Acetabular Cup System 36mm Marathon +4 Polyethylene Liner used for?

    It is used in hip joint replacement procedures as a semi-constrained metal/polymer prosthesis, consisting of an acetabular cup and polyethylene liner designed to articulate with the femoral head during hip arthroplasty.

  • Is the Duraloc Acetabular Cup System 36mm Marathon +4 Polyethylene Liner sterile or non-sterile when supplied?

    The device is supplied non-sterile and must be sterilized by the user prior to implantation, as indicated in the device description which specifies it is intended for single use after sterilization.

  • Is the Duraloc Acetabular Cup System 36mm Marathon +4 Polyethylene Liner designed for single use or reuse?

    The device is intended for single use only, as stated in the description, meaning it should be implanted once and then discarded to prevent risks associated with reprocessing such as material degradation or contamination.

  • What are the key components of the Duraloc Acetabular Cup System 36mm Marathon +4 Polyethylene Liner?

    The system consists of an acetabular cup with a porous coating and a 36mm Marathon +4 polyethylene liner, which together form a metal/polymer bearing surface designed for durability and stability in hip replacement surgery.

  • What regulatory pathway was used for the Duraloc Acetabular Cup System 36mm Marathon +4 Polyethylene Liner?

    The device received FDA 510(k) clearance under submission K010171 on April 6, 2001, based on a determination of substantial equivalence to previously cleared hip prosthesis devices under regulation 888.3358 with product code LPH.