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Sirus® 02.02149.054

by Zimmer, Inc.

Ref 02.02149.054

Sirus® 02.02149.054 is a device classified as Class IIb in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-00889024290778), cleared under FDA 510(k) K043270 on 31 Jan 2005 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI 00889024290778), active as of 25 Oct 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) K043270

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024290778 Basic UDI-DI 00889024290778UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024290778 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK043270 Date31 Jan 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024290778 registered 19 Oct 2026 Active
  • FDA 510(k) K043270 decided 31 Jan 2005 Active
  • FDA GUDID UDI-DI 00889024290778 listed 29 Aug 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0247-2013 FDA Class II initiated 4 Sep 2012

    Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

    • Terminated Z-1261-2009 FDA Unclassified (pre-2012) initiated 23 Mar 2009

    The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.

Timeline

5 dated events

  1. Cleared FDA 510(k) K043270
  2. Recall initiated FDA recalls Z-1261-2009
  3. Recall initiated FDA recalls Z-0247-2013
  4. Listed FDA GUDID 00889024290778
  5. Registered EUDAMED B-00889024290778

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
Locking screw EUDAMED
Sirus® GUDID
Generic name
Femur intramedullary nail
Device name
Locking-screw ø 4.9 mm, self-tapping
Model / reference
02.02149.054
Primary DI / UDI-DI
00889024290778
Basic UDI-DI
B-00889024290778
510(k) Number
FDA product code
HSB
EMDN code
P09088099 Hip prostheses - other accessories
GMDN term
Femur intramedullary nail
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 54 Millimeter
Outer Diameter — 4.9 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: Femur intramedullary nail

Cleared under the same submission (K043270)

and 8 more cleared under K043270

Similar devices in this category

Other devices filed under HIP PROSTHESES - OTHER ACCESSORIES.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

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