Device Dossier

Orthopaedic fixation plate, non-biodegradable

Device Dossier for Orthopaedic fixation plate, non-biodegradable (Orthopaedic fixation plate, non-biodegradable, Class IIb, sponsor Akva Surgical). ARTG…

Intended purpose

Shell Calcaneus Implant is intended for the treatment of planovalgus foot deformity in cerebral palsy (CP) by calcaneal lengthening. The plate can be inserted into the osteotomy gap based on the amount of talonavicular coverage. Indications are Pes Planovalgus deformity, Hindfoot valgus, Midfoot plantar flexion, Collapsed medial longitudinal arc and Forefoot supination.

TGA Public Summary