INDICATIONS, SAFETY, AND WARNINGS FiberCel

FiberCel is a human tissue allograft consisting of cryopreserved cancellous and corticocancellous bone matrix that is aseptically processed to preserve native factors that support bone repair. FiberCel is a Human Cellular and Tissue Based Product (HCT/P) per 21 CFR Part 1271. Each allograft is restricted to homologous use for transplant in procedures for repair, replacement or reconstruction on a single occasion by a licensed physician or surgeon. FiberCel can be used in orthopedic or reconstructive bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft.

Contraindications: The presence of infection at the transplant site is a contraindication for the use of this allograft.