The FDA has granted 510(k) clearance to Israeli-based Ossio's Ltd.'s bio-integrative material indicated "for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace)." The Pin Product Family, according to FDA documents, "is a fixation device made of degradable poly (L-lactide-co-D, Llactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body." The mineral fibers are made from materials that are incorporated into bone.
The implants are supplied sterile and are available in several sizes: 10-70mm long and 2-4mm nominal dimension, and with a circular, hexagonal or octagonal crosssectional design.