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Trident 643-00-28J

by Howmedica Osteonics Corp.

Ref 643-00-28JModel 08858251002286SY

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

CE MDR

Valid until

21 Jun 2031

CE MDR certificate

FDA recalls

None ongoing

2 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002286SY Basic UDI-DI 07613327025729UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327025729 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 730291 Active Reissued

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    12 Jun 2026
    Expires
    21 Jun 2031
    Valid from
    22 Jun 2026

Recalls

2 recalls · FDA

    • Terminated Z-2810-2015 FDA Class II initiated 25 Jun 2015

    it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.

    • Terminated Z-0909-2010 FDA Unclassified (pre-2012) initiated 17 Feb 2006

    Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.

Coverage

2 jurisdictions

United States of AmericaNorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Map note: Northern Ireland has no dot of its own.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Specification

EUDAMED · GUDID

Trade Name
Trident® X3® EUDAMED
Trident GUDID
Generic Name
Non-constrained polyethylene acetabular liner
Device Name
DD-013 - Trident X3 - Gas Plasma
Model / Ref / Catalog
643-00-28J, 08858251002286SY
Primary DI / UDI-DI
07613327025729
Basic UDI-DI
08858251002286SY
510(k) Number
FDA Product Code
LZO, JDI, MEH, LWJ, LPH
EMDN Code
P090803040103 Retentive polyethylene hip prostheses inserts, anti-dislocation
GMDN Term
Non-constrained polyethylene acetabular liner
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3350, 888.3360, 888.3358
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 28.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K033716)

Show all (12)

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (19)

  • 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