www.fdanews.com/articles/202814-biorez-receives-fda-clearance-for-soft-tissue-scaffold
Biorez Receives FDA Clearance for Soft-Tissue Scaffold
May 19, 2021
The FDA has granted Biorez 510(k) clearance for its BioBrace Implant, a soft-tissue scaffold designed for use in a range of surgical procedures.
The biocomposite scaffold reinforces soft tissue in weak areas and can be used with existing surgical techniques and instruments.
The implant features a highly porous collagen matrix and resorbable poly-L-lactide microfilaments that enable the scaffold to reinforce tendon and ligament repairs and encourage healing.