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Unity Total Knee System 112.060.44

by Corin Ltd

Ref 112.060.44Model Unity Total Knee System

Unity Total Knee System 112.060.44 is a device classified as Class IIb in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-05055343896167), cleared under FDA 510(k) K170808 on 13 Jul 2017 and listed in FDA GUDID since 28 Sep 2017 (UDI-DI 05055343896167), active as of 24 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 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055343896167 Basic UDI-DI 05055343896167UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343896167 UDI-DI Date28 Sep 2017ListedStatusListed 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-05055343896167 registered 16 Sep 2026 Active
  • FDA 510(k) K170808 decided 13 Jul 2017 Active
  • FDA GUDID UDI-DI 05055343896167 listed 28 Sep 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170808
  2. Listed FDA GUDID 05055343896167
  3. Registered EUDAMED B-05055343896167

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  • Withdrawn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 Stem Ø14.0mm/L30.0mm Stem Extension-Ti (For Cemented use) EUDAMED
Unity Total Knee System GUDID
Generic name
Knee femur stem prosthesis
Device name
Unity Knee Stem Extensions for use in total knee arthroplasty
Model / reference
112.060.44, Unity Total Knee System
Primary DI / UDI-DI
05055343896167
Basic UDI-DI
B-05055343896167
510(k) Number
FDA product code
JWH
EMDN code
P0909800601 Knee prostheses femoral stems
GMDN term
Knee femur stem prosthesis
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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 femur stem prosthesis

Cleared under the same submission (K170808)

and 8 more cleared under K170808

Similar devices in this category

Other devices filed under KNEE PROSTHESES FEMORAL STEMS.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)