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DePuy PINNACLE Dual Mobility Liner

by DePuy Ireland UC

510(k) K200854

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200854↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK200854 Date11 Sep 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 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 DePuy PINNACLE Dual Mobility Liner is a modular cobalt-chrome-molybdenum alloy implant designed for total hip arthroplasty. It functions as a dual-articulation construct, featuring a taper-locking mechanism for secure assembly into the PINNACLE Acetabular Shells. This design enhances range of motion and stability in hip replacements by providing a dual-bearing surface.

Intended for single-use only, the liner is supplied sterile and requires surgical implantation by an orthopedic specialist. It is classified as a Class 2 Orthopedic device under FDA regulations, cleared via the Traditional 510(k) pathway (K200854). Compliance with MDR standards is also noted. Storage and handling must adhere to sterile medical device protocols to maintain integrity before use.

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