Device Dossier

Orthopaedic bone screw, non-bioabsorbable, sterile

Device Dossier for Orthopaedic bone screw, non-bioabsorbable, sterile (Orthopaedic bone screw, non-bioabsorbable, sterile, Class IIb, sponsor Stryker).…

Intended purpose

An ancillary component designed to be used in total reconstructive replacement of the knee joint. Indications: • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. • Post-traumatic loss of knee joint configuration and function. • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. • Revision of previous unsuccessful knee replacement or other procedure. • Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques.

TGA Public Summary