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Medpor Titan 81020

by Stryker Leibinger

Ref 81020

Medpor Titan 81020 is a device classified as Class IIb in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-07613252084211), cleared under FDA 510(k) K040364 on 30 Jun 2004 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613252084211), active as of 7 Nov 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K040364

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07613252084211 Basic UDI-DI 07613252084211UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252084211 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK040364 Date30 Jun 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07613252084211 registered 5 Nov 2026 Active
  • FDA 510(k) K040364 decided 30 Jun 2004 Active
  • FDA GUDID UDI-DI 07613252084211 listed 24 Sep 2015 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0715-2022 FDA Class II initiated 29 Dec 2021

    Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

    • Terminated Z-1093-2015 FDA Class II initiated 17 Dec 2014 on shared 510(k) K040364

    Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment. However, the products had an incorrect barrier location.

    • Terminated Z-0922-2012 FDA Unclassified (pre-2012) initiated 16 Dec 2011

    The template that is packaged with this implant was not packaged according to specification. The template was packaged in a single pouch instead of a double pouch.

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

Timeline

6 dated events

  1. Cleared FDA 510(k) K040364
  2. Recall initiated FDA recalls Z-0922-2012
  3. Recall initiated FDA recalls Z-1093-2015
  4. Listed FDA GUDID 07613252084211
  5. Recall initiated FDA recalls Z-0715-2022
  6. Registered EUDAMED B-07613252084211

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Medpor Titan
Generic name
Polyethylene craniofacial tissue reconstructive material
Model / Ref / Catalog
81020
Primary DI / UDI-DI
07613252084211
Basic UDI-DI
B-07613252084211
510(k) Number
FDA product code
FTM
EMDN code
P900403 Non-resorbable filling and reconstruction devices
GMDN term
Polyethylene craniofacial tissue reconstructive material
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.3300
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Width — 50.0 Millimeter
Length — 76.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Polyethylene craniofacial tissue reconstructive material

Cleared under the same submission (K040364)

and 8 more cleared under K040364

Similar devices in this category

Other devices filed under NON-RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

Other devices from Stryker Leibinger

  • 92-55772

    Class II

  • 92-55773

    Class II

  • 92-55771

    Class II

  • 92-55770

    Class II

See all devices from Stryker Leibinger →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)