Wright Medical Group has received approval from the FDA to conduct an Investigational Device Exemption clinical study to investigate the use of INBONE total ankle replacement, according to a company news release.
IBONE is a total ankle replacement system with calcaneal stem for treating end-stage ankle arthritis or revision of a failed ankle replacement with subtalar joint insufficiency
The device includes a component fixation into the calcaneus, which allows surgeons to perform more complex procedures as an alternative to fusion or amputation. This is the first FDA-approved IDE to measure clinical outcomes in total ankle replacement that utilizes calcaneal fixation, according to the report.
Read the release on Wright Medical Groups trail of INBONE.
Read other coverage on Wright Medical Group:
- Wright Medical Group Signs Distribution Agreement With AlloSource
- Wright Medical Group Launches Limited Release of Hammertoe Fixation System
- Wright Medical Launches Bone Graft Substitute
IBONE is a total ankle replacement system with calcaneal stem for treating end-stage ankle arthritis or revision of a failed ankle replacement with subtalar joint insufficiency
The device includes a component fixation into the calcaneus, which allows surgeons to perform more complex procedures as an alternative to fusion or amputation. This is the first FDA-approved IDE to measure clinical outcomes in total ankle replacement that utilizes calcaneal fixation, according to the report.
Read the release on Wright Medical Groups trail of INBONE.
Read other coverage on Wright Medical Group:
- Wright Medical Group Signs Distribution Agreement With AlloSource
- Wright Medical Group Launches Limited Release of Hammertoe Fixation System
- Wright Medical Launches Bone Graft Substitute