Altius
Basic Information
- Primary DI
- 08902618005021
- Basic UDI-DI Code
- B-08902618005021
- Reference
- BPFR2
- 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 superior surface of the femoral component contains twin fixation pins. The articular geometry, composed of two different radii, is swept around a series of parallel axes to form the profile in the sagittal plane. Therefore, each condyle and the anterior surface are composed of two convex and one, central concave surfaces. This configuration allows for congruity to be maintained during Valgus-Varus tilts and patellar tilts. The femoral sulcus is a deep, groove that accommodates congruent, anatomic, patellar prosthesis. The femoral component is available in six sizes, with separate versions for the right and left leg. The Knee Femoral component is supplied in sterile condition after being sterilised using the Ethylene Oxide sterilization process
CND Nomenclature Codes
| Code | Description |
|---|---|
| P0909030101 | BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS |
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).