Materials and structure
Discuss ligament materials and braided structures for the intended use
05 / SPORTS MEDICINEArtificial ligament reconstruction
Artificial ligament reconstruction
and sports medicine devices
Discuss design and manufacturing for soft-tissue repair needs.
ARTIFICIAL LIGAMENT / SPORTS MEDICINE
Device development needs for artificial ligament reconstruction.
Sports medicine projects can start with materials, structure, fixation interfaces and intended use. Product classification and design or manufacturing activities are confirmed against applicable TFDA QMS categories and project information.
Fixation interfaces
Review bone fixation components and use requirements
QMS scope review
Confirm applicable categories, including passive tendon prostheses, case by case
An ITRI public report describes OSSAWARE's participation in a cross-sector composite regenerative ligament industry collaboration, with the technology still progressing toward clinical trials and commercialization planning.Read the ITRI report ↗
SPORTS MEDICINESports medicine,
Sports medicine,
starting with product needs.
The supplied QMS scope includes passive tendon prostheses. Whether an artificial ligament reconstruction application fits this category and its permitted activities depends on the specific product and approval documents.
View TFDA QMS scope ↗