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00-5853-050-09

by Zimmer, Inc.

Ref 00-5853-050-09

00-5853-050-09 is a device classified as Class IIa in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00889024198395), cleared under FDA 510(k) K101296 on 30 Jul 2010 and listed in FDA GUDID since 24 May 2016 (UDI-DI 00889024198395), 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) K101296

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-00889024198395 Basic UDI-DI 00889024198395UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024198395 UDI-DI Date24 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK101296 Date30 Jul 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024198395 registered 2 Nov 2026 Active
  • FDA 510(k) K101296 decided 30 Jul 2010 Active
  • FDA GUDID UDI-DI 00889024198395 listed 24 May 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1381-2018 FDA Class II initiated 29 Mar 2018

    There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.

    • Terminated Z-1219-2015 FDA Class II initiated 5 Feb 2015

    PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.

Timeline

5 dated events

  1. Cleared FDA 510(k) K101296
  2. Recall initiated FDA recalls Z-1219-2015
  3. Listed FDA GUDID 00889024198395
  4. Recall initiated FDA recalls Z-1381-2018
  5. Registered EUDAMED B-00889024198395

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

Generic name
Femoral stem prosthesis trial
Device name
Kn Segmental Str Stem Prov
Model / Ref / Catalog
00-5853-050-09
Primary DI / UDI-DI
00889024198395
Basic UDI-DI
B-00889024198395
510(k) Number
FDA product code
LZO, JDI, KRO, LPH
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Femoral stem prosthesis trial
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3350, 888.3510, 888.3358
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
Size
Length — 130 Millimeter

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: Femoral stem prosthesis trial

Cleared under the same submission (K101296)

and 8 more cleared under K101296

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, 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)