Altius
Basic Information
- Primary DI
- 08902618005328
- Basic UDI-DI Code
- B-08902618005328
- Reference
- BPB22
- 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
The Mobile bearing is constructed from UHMWPE (Ultrahigh molecular Weight Polyethylene). UHMWPE complies with the material standard ISO 5834-2, Type-2 / ASTM F648, fabricated form Type-2. The articular surface is constructed from the same common generating curve used to construct the femoral geometry in the frontal plane. The inferior portion of the bearing contains an integrally attached conical stem. An anterior recess is present in the bearing to clear the patellar tendon and prosthesis and a posterior notch is present to clear both soft and hard tissues that could possibly interfere with the bearing in deep flexion. Mobile Bearing is available in six sizes to match the femoral component size and it has four thicknesses from 0 through 7.5 mm in 2.5 mm increments. The Knee Mobile bearing component is supplied in sterile condition after being sterilised using Ethylene Oxide sterilization process.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P090903020201 | BICOMPARTMENTAL PRIMARY IMPLANT MOBILE BEARING TIBIAL INSERTS |
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).