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Continuum® Trilogy® 00-8831-010-28

by Zimmer, Inc.

Ref 00-8831-010-28

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024153097 Basic UDI-DI 00889024153097UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024153097 UDI-DI Date30 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

3 recalls · FDA

    • Terminated Z-0094-2015 FDA Class II initiated 1 Oct 2014

    The affected products are missing polar boss threads.

  • 2 recalls, same reason

    • Terminated Z-0071-2011 FDA Unclassified (pre-2012) initiated 19 Mar 2010 on shared 510(k) K091508
    • Terminated Z-0072-2011 FDA Unclassified (pre-2012) initiated 19 Mar 2010 on shared 510(k) K091508

    The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Continuum® Trilogy®
Generic name
Acetabulum prosthesis trial, prefabricated, reusable
Device name
Continuum Provisional Neutral Liner Assembly
Model / Ref / Catalog
00-8831-010-28
Primary DI / UDI-DI
00889024153097
Basic UDI-DI
B-00889024153097
510(k) Number
FDA product code
LZO, LPH, JDI
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Acetabulum prosthesis trial, prefabricated, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3358, 888.3350
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Lumen/Inner Diameter — 28 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Acetabulum prosthesis trial, prefabricated, reusable

Cleared under the same submission (K091508)

Show all (12)

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (22)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No