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Unity Total Knee System 123.116.24

by Corin Ltd

Ref 123.116.24Model Unity Total Knee instrument set

Unity Total Knee System 123.116.24 is a device classified as Class I in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-05055343891520), cleared under FDA 510(k) K170808 on 13 Jul 2017 and listed in FDA GUDID since 17 Oct 2018 (UDI-DI 05055343891520), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170808

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055343891520 Basic UDI-DI 05055343891520UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343891520 UDI-DI Date17 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170808 Date13 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343891520 registered 15 Oct 2026 Active
  • FDA 510(k) K170808 decided 13 Jul 2017 Active
  • FDA GUDID UDI-DI 05055343891520 listed 17 Oct 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170808
  2. Listed FDA GUDID 05055343891520
  3. Registered EUDAMED B-05055343891520

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  • Withdrawn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
Tensioner Paddle Flexion EUDAMED
Unity Total Knee System GUDID
Generic name
Orthopaedic knee-balance analyser, non-electrical
Model / Ref / Catalog
123.116.24, Unity Total Knee instrument set
Primary DI / UDI-DI
05055343891520
Basic UDI-DI
B-05055343891520
510(k) Number
FDA product code
JWH
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic knee-balance analyser, non-electrical
Device class
Class I 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
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Orthopaedic knee-balance analyser, non-electrical

Cleared under the same submission (K170808)

and 8 more cleared under K170808

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)