Gaps in post-implantation traceability
- Loss of knee arthroplasty traceability after implantation
- Insufficiently completed national registers
Nowadays, the traceability of a product from food industry is much better guaranteed than of medical device implanted in a patient.
Lack of information after implantation
- Few data about post-implantation knee arthroplasty behaviour
- Mechanical wear of knee arthroplasties over time, mainly inducing bone adhesion loosening
These days, the only common tool for health professionals to use in order to assess the knee arthroplasty behavior is the X-ray radiography.
The radiography provides a static picture of the joint, giving few opportunities to detect a bone adhesion loosening and does not provide any information about the knee arthroplasty kinematic.
A solution for connected and smart knee arthroplasties
A real time system for dynamic 3D in vivo representation of the kinematics of total knee arthroplasties.
These solutions are developed in compliance with the regulatory framework imposed to medical devices, and according to the ISO 13485:2016 quality system management implemented at BoneTag.