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Unity Total Knee System 1125166

by Corin Ltd

Ref 1125166Model Unity Total Knee System

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05056139236112 Basic UDI-DI 05056139236112UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139236112 UDI-DI Date17 Jul 2019ListedStatusListed 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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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 Knee™ CS Insert Size 4/14.0mm Fixed Condylar Stabilised -UHMWPE EUDAMED
Unity Total Knee System GUDID
Generic Name
Tibial insert
Device Name
Unity Knee™ Fixed Condylar-Stabilised UHMWPE Insert for Total Knee Arthroplasty
Model / Ref / Catalog
1125166, Unity Total Knee System
Description
Tibial Insert CS Fixed #4 Th14
Primary DI / UDI-DI
05056139236112
Basic UDI-DI
B-05056139236112
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 market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Tibial insert

Cleared under the same submission (K183533)

Show all (12)

Other devices from Corin Ltd

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: 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
  • Manufacturing Date: No