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Unity Total Knee System 1125105

by Corin Ltd

Ref 1125105Model Unity Total Knee System

Unity Total Knee System 1125105 is a device classified as Class III in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-05056139235771), cleared under FDA 510(k) K183533 on 4 Jun 2019 and listed in FDA GUDID since 17 Jul 2019 (UDI-DI 05056139235771), active as of 22 Oct 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183533

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05056139235771 Basic UDI-DI 05056139235771UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139235771 UDI-DI Date17 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183533 Date4 Jun 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05056139235771 registered 16 Sep 2026 Active
  • FDA 510(k) K183533 decided 4 Jun 2019 Active
  • FDA GUDID UDI-DI 05056139235771 listed 17 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183533
  2. Listed FDA GUDID 05056139235771
  3. Registered EUDAMED B-05056139235771

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  • Withdrawn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
Unity Knee™ CS Insert Size 1/12.0mm Fixed Condylar Stabilised -UHMWPE EUDAMED
Unity Total Knee System GUDID
Generic name
Tibial insert
Device name
Unity Knee™ Fixed Condylar-Stabilised UHMWPE Insert for Total Knee Arthroplasty
Model / Ref / Catalog
1125105, Unity Total Knee System
Description
Tibial Insert CS Fixed #1 Th12
Primary DI / UDI-DI
05056139235771
Basic UDI-DI
B-05056139235771
510(k) Number
FDA product code
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
888.3560
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

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 05056139235771: 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

Cleared under the same submission (K183533)

and 8 more cleared under K183533

Similar devices in this category

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

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

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