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Unity Total Knee System 1122310

by Corin Ltd

Ref 1122310Model Unity Total Knee System

Unity Total Knee System 1122310 is a device classified as Class IIb in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI B-05055343897324), cleared under FDA 510(k) K173884 on 17 Jan 2018 and listed in FDA GUDID since 6 Mar 2018 (UDI-DI 05055343897324), 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) K173884

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-05055343897324 Basic UDI-DI 05055343897324UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343897324 UDI-DI Date6 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173884 Date17 Jan 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343897324 registered 23 Sep 2026 Active
  • FDA 510(k) K173884 decided 17 Jan 2018 Active
  • FDA GUDID UDI-DI 05055343897324 listed 6 Mar 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173884
  2. Listed FDA GUDID 05055343897324
  3. Registered EUDAMED B-05055343897324

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  • Withdrawn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
Femoral Distal Augment 5mm sizes 5. 6 & 7 EUDAMED
Unity Total Knee System GUDID
Generic name
Knee arthroplasty wedge
Device name
Unity knee system femoral augment
Model / Ref / Catalog
1122310, Unity Total Knee System
Primary DI / UDI-DI
05055343897324
Basic UDI-DI
B-05055343897324
510(k) Number
FDA product code
JWH
EMDN code
P09098001 Knee prostheses augments
GMDN term
Knee arthroplasty wedge
Device class
Class IIb 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 IIb
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 05055343897324: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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

Cleared under the same submission (K173884)

and 8 more cleared under K173884

Similar devices in this category

Other devices filed under KNEE PROSTHESES AUGMENTS.

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)