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Continuum® Trilogy® 00-8831-014-28

by Zimmer, Inc.

Ref 00-8831-014-28

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

CE MDD

Valid until

Not listed

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-00889024153233 Basic UDI-DI 00889024153233UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024153233 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  • Withdrawn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
00-8831-014-28
Primary DI / UDI-DI
00889024153233
Basic UDI-DI
B-00889024153233
510(k) Number
FDA Product Code
LZO, JDI, LPH
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, 888.3350, 888.3358
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization 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

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: 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