Skip to content

Avenir Complete® 574777441

by Zimmer, Inc.

Ref 574777441

Avenir Complete® 574777441 is a device classified as Class IIa in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00889024509863), cleared under FDA 510(k) K182048 on 7 Dec 2018 and listed in FDA GUDID since 19 Jun 2019 (UDI-DI 00889024509863), active as of 7 Nov 2026.

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 found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182048

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-00889024509863 Basic UDI-DI 00889024509863UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024509863 UDI-DI Date19 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182048 Date7 Dec 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024509863 registered 29 Oct 2026 Active
  • FDA 510(k) K182048 decided 7 Dec 2018 Active
  • FDA GUDID UDI-DI 00889024509863 listed 19 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182048
  2. Listed FDA GUDID 00889024509863
  3. Registered EUDAMED B-00889024509863

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  • Withdrawn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
Avenir Complete®
Generic name
Joint prosthesis implantation kit, reusable
Device name
HP Avenir Complete Calcar Planer Spring Post Instrument
Model / Ref / Catalog
574777441
Primary DI / UDI-DI
00889024509863
Basic UDI-DI
B-00889024509863
510(k) Number
FDA product code
MEH, LZO, KWY, KWZ, LWJ
EMDN code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3390, 888.3310, 888.3360
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Joint prosthesis implantation kit, reusable

Cleared under the same submission (K182048)

and 8 more cleared under K182048

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)