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APEX Knee System EP-22612

by OMNIlife science, Inc.

Ref EP-22612Model APEX Knee System

APEX Knee System EP-22612 is a device classified as Class III in the EU and Class II in the US made by OMNIlife science, Inc., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI B-00841690133834) and listed in FDA GUDID since 25 Sep 2021 (UDI-DI 00841690133834), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841690133834 Basic UDI-DI 00841690133834UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690133834 UDI-DI Date25 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841690133834 registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 00841690133834 listed 25 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841690133834
  2. Registered EUDAMED B-00841690133834

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
APEX Knee System Size 6 x 12mm (ECiMa) PS-C Insert EUDAMED
APEX Knee System GUDID
Generic name
Tibial insert
Device name
Apex total knee (EciMa) PS-C insert intended for use as primary or revision total knee replacement
Model / Ref / Catalog
EP-22612, APEX Knee System
Primary DI / UDI-DI
00841690133834
Basic UDI-DI
B-00841690133834
FDA product code
MBH, JWH
EMDN code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
GMDN term
Tibial insert
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3565, 888.3560
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00841690133834: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class III 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: Tibial insert

Similar devices in this category

Other devices filed under BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS.

Other devices from OMNIlife science, Inc.

See all devices from OMNIlife science, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)