U2 Total Knee System

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

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

• • Ongoing Z-2883-2026 FDA Class II ·initiated 20 May 2026

  Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

• 2 recalls, same reason

  • Terminated Z-1129-2018 FDA Class II ·initiated 24 Nov 2017
  • Terminated Z-1128-2018 FDA Class II ·initiated 24 Nov 2017

  UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.

Trade Name

U2 Total Knee System EUDAMED

E-XPE Tibial insert, CR GUDID

Generic Name

Cruciate-retaining total knee prosthesis

Device Name

U2 Total Knee System E-XPE Tibial Insert, Cruciate Retaining, #4, 13mm Thick

Model / Ref / Catalog

2303-1843

Primary DI / UDI-DI

04719872151227

Basic UDI-DI

B-04719872151227

510(k) Number

K161705 ↗

FDA Product Code

JWH, MBH, OIY

EMDN Code

P090903020202 Bicompartmental primary implant fixed bearing tibial inserts

GMDN Term

Cruciate-retaining total knee prosthesis

Device Class

Class III EUDAMED

Class II GUDID

Regulation Number

888.3560, 888.3565

EU market of registration

France

GUDID distribution status

In Commercial Distribution

EUDAMED SRN

TW-MF-000009523

Authorised representative

mdi Europa GmbH DE-AR-000006218

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  Class III

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• What is the U2 Total Knee System E-XPE Tibial Insert specifically designed for in knee replacement surgery?

  The U2 Total Knee System E-XPE Tibial Insert, Cruciate Retaining (#4, 13mm thick), is designed as a polyethylene bearing surface for total knee arthroplasty. It articulates with femoral components to provide a smooth, weight-bearing surface for load distribution in the knee joint, preserving the anterior cruciate ligament (cruciate-retaining design). This insert is part of a Class III implantable knee prosthesis system and is intended exclusively for surgical implantation.

• Is this tibial insert reusable, and how should it be handled to maintain sterility?

  The U2 Total Knee System E-XPE Tibial Insert is single-use only and must be handled under aseptic conditions before implantation. It is pre-sterilized (as indicated by the sterility field) and comes as part of the U2 Total Knee System. Reuse is contraindicated, and proper storage per manufacturer guidelines is required to preserve sterility.

• What safety precautions should clinicians take when using this device, particularly regarding imaging?

  This tibial insert is MRI-unsafe due to its metallic and polymer composition. Clinicians should avoid MRI scans for patients with this implant, as the device may pose risks in magnetic fields. Always confirm compatibility with imaging modalities before scheduling scans.

• How can I verify the regulatory compliance and traceability of this device?

  The U2 Total Knee System E-XPE Tibial Insert holds FDA 510(k) clearance (K082424) and complies with the Medical Devices Directive (MDD). It includes a UDI (Unique Device Identifier) for traceability, with the Basic UDI being `B-04719872151227`. This ensures traceability from manufacturing to implantation, as required by regulatory standards.

• What sizes or models of this tibial insert are available, and how are they differentiated?

  The U2 Total Knee System E-XPE Tibial Insert is available in specific sizes and thicknesses, with the example model listed as #4, 13mm thick. The nomenclature code `P090903020202` confirms it is a cruciate-retaining tibial insert for knee replacements. Additional sizes may exist within the broader U2 Total Knee System, but the exact range should be confirmed with the manufacturer or product documentation.