Wright Medical Group's BioMimetic subsidiary received an approval order for its premarket approval application from the FDA for its AUGMENT Bone Graft, according to a Med Device Online report.
Here are four points:
1. Wright Medical can now initiate commercial sale and distribution of the bone graft in the United States.
2. The bone graft is intended as an alternative to autograft for ankle and/or hindfoot fusion indications.
3. The bone graft features a combination of two components — recombinant human Platelet-Derived Growth Factor and Beta-tricalcium phosphate.
4. The bone graft has undergone clinical trial and testing, and the FDA's PMA application approval indicates that the FDA has determined that the graft is safe and effective.