FDA Cleared Bone Graft Substitutes
Vitrium received FDA 510(k) clearance as bone graft substitute for a range of implant shapes for use in non-load bearing applications. The implants may be trimmed to fit intraoperatively and may also be drilled and tapped for screw insertion.
The implants below are designed for use in the mid-foot for correction of adult flatfoot deformity through anatomical realignment of cuneiform and/or calcaneus and are distributed in the United States by In2Bones.
Vitrium E for use in Evans osteotomies
Vitrium C for use in Cotton osteotomies
Case review recently published in Foot and Ankle International
Preliminary Experience Using Bioactive Glass Wedges for Cotton Osteotomy, Borenstein, Gonzalez, Krevolin, Den Hartog, Thordarson, Foot & Ankle Orthopaedics, 2018, Vol. 3(4) 1-5.
Investigational Device. Limited by United States law to Investigational use only.
Vitrium Cervical Interbody Fusion Device
An FDA clinical trial was initiated in the second quarter of 2019 to evaluate the Vitrium device in comparison to an allograft (cadaver bone) control implant.