Depuy Synthes

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 on record, checked 24 Oct 2026.

Generic Name

Knee arthroplasty wedge

Device Name

Cemented Sleeves

Model / Ref / Catalog

Universal Cemented Sleeves, 1294-53-205, 129453205

Primary DI / UDI-DI

10603295026259

Basic UDI-DI

0603295a004428S

FDA Product Code

NJL, JWH

EMDN Code

P09098002 Knee prostheses adapters (including cones and sleeves)

GMDN Term

Knee arthroplasty wedge

Device Class

Class IIb EUDAMED

Class III GUDID

Regulation Number

888.3560

Market of Registration

Ireland

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Conditional

EUDAMED SRN

IE-MF-000007377

• Cemented RP Tibial Insert

  Class III

  CE/MDR MDR 755208 Active Valid to Jul 2029

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  CE/MDR

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  Class III

  CE/MDR MDR 755208 Active Valid to Jul 2029

See all devices from DePuy Ireland UC →