Altius
Basic Information
- Primary DI
- 08902618005144
- Basic UDI-DI Code
- B-08902618005144
- Reference
- BPT2
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- TTK Healthcare Limited (Ortho Division)
Additional Description
Constructed of Co-Cr alloy which complies with the material standard ISO 5832-4 / ASTM F75. Cemented version has to be used with bone cement for fixing the component with the bone. The component allows for axial rotation of the bearing surface, with ML and AP constraint. The tibial tray consists of a flat tibial loading plate with an integrally attached, conical fixation stem. The superior surface of the tray contains a conical, female hole. The loading plate and female cone are highly polished. A rotational stop pin is fixed to the anterior superior portion of the tibial tray. Tibial platform is available in six sizes. The Knee Tibial Platform component is supplied in sterile condition after being sterilised using Ethylene Oxide sterilization process
CND Nomenclature Codes
| Code | Description |
|---|---|
| P090903020101 | BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED MOBILE BEARING TIBIAL PLATES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 11251-2017-CE-IND-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).