Skip to content

Interference Screw 909658

by Biomet Orthopedics, Inc.

Ref 909658

Interference Screw 909658 is a device classified as Class IIb in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-00880304005532), cleared under FDA 510(k) K193451 on 24 Feb 2020 (1 earlier submission) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304005532), 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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193451

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00880304005532 Basic UDI-DI 00880304005532UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193451 Date24 Feb 2020DecidedStatusActive
United StatesGUDID listing GUDID Number00880304005532 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00880304005532 registered 26 Oct 2026 Active
  • FDA 510(k) K193451 decided 24 Feb 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304005532 listed 24 Oct 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0630-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

    • Terminated Z-0753-2013 FDA Class II initiated 3 Jan 2013

    Thru hole at the tip of the screw is undersized.

Timeline

6 dated events

  1. Cleared FDA 510(k) K934469
  2. Recall initiated FDA recalls Z-0753-2013
  3. Listed FDA GUDID 00880304005532
  4. Cleared FDA 510(k) K193451
  5. Recall initiated FDA recalls Z-0630-2021
  6. Registered EUDAMED B-00880304005532

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
Interference Screw
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Device name
Round Head TI Interference Screw Implant
Model / Ref / Catalog
909658
Primary DI / UDI-DI
00880304005532
Basic UDI-DI
B-00880304005532
510(k) Number
FDA product code
HWC, MBI
EMDN code
P09120605 Interference screws
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

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: Tendon/ligament bone anchor, non-bioabsorbable

Cleared under the same submission (K193451)

and 8 more cleared under K193451

Cleared under the same submission (K934469)

and 8 more cleared under K934469

Similar devices in this category

Other devices filed under INTERFERENCE SCREWS.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)