Device Dossier
Orthopaedic implantation application software
Device Dossier for Orthopaedic implantation application software (Orthopaedic implantation application software, Class IIa, sponsor Akunah). ARTG record,…
- GMDN category: Orthopaedic implantation application software
Intended purpose
Akunah Reflect Planning Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The software is used to assist in the positioning of shoulder components. Akunah Reflect Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. The software leads to the generation of a planning report. The software is to be used for adult patients only and should not be used for diagnostic purposes. Akunah Reflect should be used in conjunction with expert clinical judgement.