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OMNI Knee KC-53104

by OMNIlife science, Inc.

Ref KC-53104Model APEX Knee System

OMNI Knee KC-53104 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 2 Oct 2026 (Basic UDI-DI B-00841690111733) and listed in FDA GUDID since 27 Nov 2015 (UDI-DI 00841690111733), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841690111733 Basic UDI-DI 00841690111733UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690111733 UDI-DI Date27 Nov 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841690111733 registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 00841690111733 listed 27 Nov 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841690111733
  2. Registered EUDAMED B-00841690111733

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  • Withdrawn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 4mm Revision Tibia Augment Bolt EUDAMED
OMNI Knee GUDID
Generic name
Knee arthroplasty wedge
Device name
Apex total knee tibial augment bolt for use as a primary or revision total knee replacement
Model / Ref / Catalog
KC-53104, APEX Knee System
Primary DI / UDI-DI
00841690111733
Basic UDI-DI
B-00841690111733
FDA product code
JWH, MBH
EMDN code
P090999 Knee prostheses - other
GMDN term
Knee arthroplasty wedge
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3560, 888.3565
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 00841690111733: 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: Knee arthroplasty wedge

Similar devices in this category

Other devices filed under KNEE PROSTHESES - OTHER.

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)