Skip to content

A.l.p.s.® 110017618

by Biomet Orthopedics, Inc.

Ref 110017618

A.l.p.s.® 110017618 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 23 Oct 2026 (Basic UDI-DI B-00887868530135), cleared under FDA 510(k) K173767 on 6 Apr 2018 (1 earlier submission) and listed in FDA GUDID since 6 Aug 2021 (UDI-DI 00887868530135), active as of 7 Nov 2026. 3 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) K173767

+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-00887868530135 Basic UDI-DI 00887868530135UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868530135 UDI-DI Date6 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173767 Date6 Apr 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00887868530135 registered 23 Oct 2026 Active
  • FDA 510(k) K173767 decided 6 Apr 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00887868530135 listed 6 Aug 2021 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0882-2021 FDA Class II initiated 23 Dec 2020

    The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.

  • 2 recalls, same reason

    • Terminated Z-2308-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2310-2020 FDA Class II initiated 14 May 2020

    Distributed to the field without having completed design history files or design transfer activities

Timeline

7 dated events

  1. Cleared FDA 510(k) K083843
  2. Cleared FDA 510(k) K173767
  3. Recall initiated FDA recalls Z-2308-2020
  4. Recall initiated FDA recalls Z-2310-2020
  5. Recall initiated FDA recalls Z-0882-2021
  6. Listed FDA GUDID 00887868530135
  7. Registered EUDAMED B-00887868530135

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
A.l.p.s.®
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
ALPS T15 3_5mm LP cortical nonlocking screw ST
Model / Ref / Catalog
110017618
Primary DI / UDI-DI
00887868530135
Basic UDI-DI
B-00887868530135
510(k) Number
FDA product code
HRS
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K083843)

and 8 more cleared under K083843

Cleared under the same submission (K173767)

and 8 more cleared under K173767

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

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