Device Dossier
Active Knee Tibial Implant Stemmed, Cementless - Coated knee tibia prosthesis
Device Dossier for Active Knee Tibial Implant Stemmed, Cementless - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor…
- GMDN category: Coated knee tibia prosthesis
Intended purpose
The stemmed tibial implant is a component of the Active Knee System. The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support prosthesis. It is intended for Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis; Functional deformity such as varus, valgus or flexion deformities; Revision procedures where other treatments or devices have failed; Fractures that are unmanageable using other techniques.
Functional description
The stemmed tibial implant is symmetrical. The stemmed implants are manufactured from cast cobalt-chrome-molybdenum (CoCrMo). The interior surface of the cementless tibial implants, has a beaded surface and a hydroxyapatite coating to encourage bony ingrowth on the prosthesis.