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Unity Total Knee System 1231031

by Corin Ltd

Ref 1231031Model Unity Total Knee instrument set

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Overview

The Unity Total Knee System is a high-performance, orthopaedic implant designed for total knee replacement surgeries. This advanced device features a unique jig-like design with prefabricated holes and a reusable attachment point, allowing surgeons to precision-cut and guide other instruments during the procedure. The Unity Total Knee System has undergone rigorous testing and has been certified as compliant with regulatory standards for new orthopaedic devices.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05056139232978 Basic UDI-DI 05056139232978UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139232978 UDI-DI Date20 Sep 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Unity ASC Femoral PS Saw Resection Guide Std EUDAMED
Unity Total Knee System GUDID
Generic Name
Orthopaedic implant aiming/guiding block, reusable
Model / Ref / Catalog
1231031, Unity Total Knee instrument set
Primary DI / UDI-DI
05056139232978
Basic UDI-DI
B-05056139232978
510(k) Number
FDA Product Code
JWH
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN Term
Orthopaedic implant aiming/guiding block, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3560
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Orthopaedic implant aiming/guiding block, reusable

Cleared under the same submission (K113060)

Show all (12)

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No