Where the device is intended as structural support in load-bearing bone & in articulating surfaces. Severe vascular or neurological disease. Uncontrolled diabetes. Severe degenerative bone disease. Uncooperative patients who will not or cannot follow post-op instructions, including those who abuse drugs &/or alcohol. Renal impairment. Active or latent infection in or around the surgical site. Significant vascular impairment proximal to the implantation site. Metabolic or systemic bone disorders that affect bone or wound healing or stabilization of defect is not possible. Intraoperative soft tissue coverage is not planned or possible. Infected or contaminated sites.