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Unity Total Knee System 112.015.26

by Corin Ltd

Ref 112.015.26Model Unity Total Knee System

Unity Total Knee System 112.015.26 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-05055343874899), cleared under FDA 510(k) K113060 on 10 Sep 2012 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 05055343874899), active as of 25 Oct 2026. 3 FDA recalls are linked to it.

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

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K113060

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-05055343874899 Basic UDI-DI 05055343874899UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343874899 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113060 Date10 Sep 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343874899 registered 16 Sep 2026 Active
  • FDA 510(k) K113060 decided 10 Sep 2012 Active
  • FDA GUDID UDI-DI 05055343874899 listed 17 Aug 2016 Listed

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0213-2024 FDA Class II initiated 13 Oct 2023
    • Ongoing Z-0214-2024 FDA Class II initiated 13 Oct 2023

    Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

    • Terminated Z-0273-2023 FDA Class II initiated 31 Oct 2022

    The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

Timeline

6 dated events

  1. Cleared FDA 510(k) K113060
  2. Listed FDA GUDID 05055343874899
  3. Recall initiated FDA recalls Z-0273-2023
  4. Recall initiated FDA recalls Z-0213-2024
  5. Recall initiated FDA recalls Z-0214-2024
  6. Registered EUDAMED B-05055343874899

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 CR Insert Size 7/14.0mm Fixed Cruciate Retaining-UHMWPE EUDAMED
Unity Total Knee System GUDID
Generic name
Tibial insert
Device name
Unity knee tibial insert fixed cruciate retaining-UHMWPE for use in total knee arthroplasty
Model / Ref / Catalog
112.015.26, Unity Total Knee System
Description
Unity Tibial Insert CR Fixed Size 7 14mm
Primary DI / UDI-DI
05055343874899
Basic UDI-DI
B-05055343874899
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 05055343874899: 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 (K113060)

and 8 more cleared under K113060

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)