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.

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

Device Name

U2 Total Knee System Tibial Insert, Mobile Bearing, #5, 15mm Thick

U2 Total Knee System Tibial Insert, MBC, #2, 11mm Thick

Tibial insert trial, MB, #4, 18mm

U2 Total Knee System XPE Tibial Insert, Mobile Bearing, #2, 9mm Thick

U2 Total Knee System E-XPE Tibial Insert, Posterior Stabilized, #0, 17mm Thick

U2 Total Knee System XPE Tibial Insert, Mobile Bearing, #6, 11mm Thick

Tibial insert trial, PS, #4, 16mm

Tibial insert trial, MB, #4, 9mm

Tibial insert trial, MBC, #5, 11mm

Tibial insert trial, PS, #2, 17mm

Tibial insert trial, PS, #5, 10mm

U2 Total Knee System Tibial Insert, Mobile Bearing, #2, 11mm Thick

U2 Total Knee System XPE Tibial Insert, MBC, #5, 13mm Thick

Tibial insert trial, MBC, #3, 18mm

Tibial insert trial, PS, #6, 12mm

U2 Total Knee System XPE Tibial Insert, MBC, #2, 18mm Thick

U2 Total Knee System Tibial Baseplate, MBA, TPS+, #6

Tibial insert trial, MB, #3, 18mm

U2 Total Knee System XPE Tibial Insert, MBC, #6, 13mm Thick

Tibial insert trial, PS, #4, 12mm

U2 Total Knee System XPE Tibial Insert, MBC, #5, 18mm Thick

U2 Total Knee System Tibial Insert, Mobile Bearing, #6, 9mm Thick

U2 Total Knee System XPE Tibial Insert, Mobile Bearing, #1, 15mm Thick

U2 Total Knee System XPE Tibial Insert, MBC, #2, 9mm Thick

U2 Total Knee System Tibial Insert, MBC, #1, 9mm Thick

United Hip and Knee Non-sterile Reusable Instruments

Tibial insert trial, MB, #5, 18mm

Tibial insert trial, MBC, #3, 13mm

U2 Total Knee System Tibial Insert, Mobile Bearing, #2, 9mm Thick

Tibial insert trial, PS, #0, 12mm

U2 Total Knee System Tibial Insert, MBC, #5, 11mm Thick

U2 Total Knee System Tibial Insert, MBC, #1, 11mm Thick

Tibial insert trial, PS, #2, 14mm

Tibial insert trial, PS, #5, 14mm

Tibial insert trial, MB, #1, 11mm

U2 Total Knee System Femoral Augment, PS, Posterior / Distal, #1, Left

U2 Total Knee System Tibial Insert, Mobile Bearing, #6, 18mm Thick

U2 Total Knee System Tibial Baseplate, Mobile Bearing, #6

Tibial insert trial, MBC, #6, 13mm

U2 Total Knee System Tibial Insert, Posterior Stabilized, #0, 16mm Thick

U2 Total Knee System XPE Tibial Insert, Mobile Bearing, #5, 15mm Thick

Tibial insert trial, MB, #3, 13mm

U2 Total Knee System Tibial Baseplate, MBA, #2

Tibial insert trial, MBC, #2, 18mm

U2 Total Knee System Tibial Insert, Mobile Bearing, #3, 9mm Thick

U2 Total Knee System Tibial Insert, Mobile Bearing, #6, 11mm Thick

U2 Total Knee System Tibial Insert, Mobile Bearing, #6, 13mm Thick

Model / Reference

2303-7054, 2303-7222, 2303-8045, 2303-7521, 2303-3800, 2303-7562, 2303-4049-RF, 2303-8041, 2303-8252, 2303-4020-RF, 2303-4056-RF, 2303-7022, 2303-7653, 2303-8235, 2303-4067-RF, 2303-7625, 2203-7460, 2303-8035, 2303-7663, 2303-4047-RF, 2303-7655, 2303-7461, 2303-7514, 2303-7621, 2303-7211, 9303-8511, 2303-8055, 2303-8233, 2303-7021, 2303-4007-RF, 2303-7252, 2303-7212, 2303-4028-RF, 2303-4058-RF, 2303-8012, 2603-5301, 9403-6090, 2303-7065, 2203-7060, 9303-8051, 2303-8263, 9403-6040, 2303-3009, 2303-7554, 2303-8033, 2203-7220, 2303-8225, 9303-8027, 2303-7031, 2303-7462, 2303-7463

Primary DI / UDI-DI

04712602348737, 04712771496543, 04719872169239, 04711605585514, 04719872151593, 04711605585729, 04711605584036, 04719872169192, 04719872169550, 04711605583893, 04711605584050, 04712602348560, 04711605585989, 04719872169482, 04711605584111, 04711605585859, 04711605584364, 04719872169185, 04711605586030, 04711605584012, 04711605586009, 04712771496437, 04711605585491, 04711605585811, 04712771496482, 04719886893601, 04719872169284, 04719872169468, 04712602348553, 04711605583817, 04712771496697, 04712771496499, 04711605583923, 04711605584074, 04719872169055, 04712771480221, 04711605589840, 04712602348799, 04712602346191, 04719872175346, 04719872169611, 04719872157151, 04711605575119, 04711605585699, 04719872169161, 04719872178569, 04719872169437, 04711605584210, 04712602348607, 04712771496444, 04712771496451

Basic UDI-DI

B-04712602348737, B-04712771496543, B-04719872169239, B-04711605585514, B-04719872151593, B-04711605585729, B-04711605584036, B-04719872169192, B-04719872169550, B-04711605583893, B-04711605584050, B-04712602348560, B-04711605585989, B-04719872169482, B-04711605584111, B-04711605585859, B-04711605584364, B-04719872169185, B-04711605586030, B-04711605584012, B-04711605586009, B-04712771496437, B-04711605585491, B-04711605585811, B-04712771496482, 471987216TD-Ir-003F4, B-04719872169284, B-04719872169468, B-04712602348553, B-04711605583817, B-04712771496697, B-04712771496499, B-04711605583923, B-04711605584074, B-04719872169055, B-04712771480221, B-04712602348799, B-04712602346191, B-04719872169611, B-04711605575119, B-04711605585699, B-04719872169161, B-04719872178569, B-04719872169437, B-04712602348607, B-04712771496444, B-04712771496451

Direct Marketing DI

04719886893601

04711605589840

04719872175346

04719872157151

04711605584210

EMDN Code

P090903020201, L091199, P090903020202, P090903020102, P09098001, L090402, P090903020101

Device Class

Class III

Class IIa

Class I

Class IIb

Market of Registration

France

EUDAMED SRN

TW-MF-000009523

Authorised representative

mdi Europa GmbH DE-AR-000006218

• USTAR System

  Class I

  CE/MDR

• U2 Total Knee System

  Class III

  CE/MDD

• Ceramic Femoral Head

  Class III

  CE/MDD

• United Hip System

  Class III

  CE/MDD

• United Hip System 1209-1244

  Class II

  GUDID on market

• United Hip System 1209-1258

  Class II

  GUDID on market

See all devices from United Orthopedic Corp. →

• What is the U2 Total Knee System Tibial Insert, Mobile Bearing, specifically designed for in knee replacement procedures?

  The U2 Total Knee System Tibial Insert, Mobile Bearing (#5, 15mm thick), is designed to articulate with the femoral component during total knee arthroplasty. Its mobile-bearing surface is intended to reduce friction and improve joint mobility and durability, helping to enhance long-term function for patients undergoing knee replacement surgery.

• Is the U2 Total Knee System Tibial Insert reusable or single-use, and why?

  The U2 Total Knee System Tibial Insert is a single-use device, as explicitly stated in the specifications. This is standard for implantable medical devices to ensure sterility, safety, and compliance with regulatory standards, preventing any risk of contamination or degradation from reprocessing.

• What size and thickness options are available for the U2 Total Knee System Tibial Insert, and how is it supplied?

  The U2 Total Knee System Tibial Insert is currently available in one size (#5) with a fixed thickness of 15mm. It is supplied as part of the modular U2 Total Knee System, sterile and ready for surgical use, adhering to strict manufacturing and sterility protocols for implantable devices.

• How should the U2 Total Knee System Tibial Insert be stored, and what precautions should be taken?

  Since the device is sterile and single-use, it must be stored in its original packaging under clean, dry conditions, away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediate preoperative use to maintain sterility and integrity, as reprocessing or reuse is not permitted.

• What regulatory pathways does the U2 Total Knee System Tibial Insert follow, and who manufactures it?

  The U2 Total Knee System Tibial Insert complies with FDA 510K, MDD (Medical Device Directive), and MDR (Medical Device Regulation) pathways. It is manufactured by United Orthopedic Corporation, with distribution handled by mdi Europa GmbH in Germany, as indicated by the regulatory and administrative data.