Augmented Knee Arthroscopy AB - FDA 510(k) Submission

Purpose and goal

The goal of the project is to produce documentation for a proposal for approval with the FDA via 510(k), with guidance from a regulatory consultant based in the US.

Expected effects and result

Expected results is an FDA-approved product ready for introduction to the US market.

Planned approach and implementation

The implementation follows the FDA´s 510(k) track and begins with dialogue via Pre-Submissions. The clinical validation is based on a cadaver study and a clinical study in collaboration with leading orthopedic clinics. In parallel, technical and clinical documentation is developed, including software validation, risk management and human factors.