FDA Clears Titanium Bone Wedges from Integra LifeSciences

Integra LifeSciences Holdings Corp. received U.S. Food and Drug Administration 510(k) clearance for its Titanium Bone Wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle.

Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. Bone wedges are designed to provide bone grafting material for osteotomy corrections. They provide a scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. Ancillary plates are used to hold bone graft material in place and prevent it from expulsion.

The Integra Titanium Bone Wedges may be used in corrective procedures, such as Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. They are made of commercially pure titanium formed into a cancellous-like structure that mimics the strength and porosity of human bone. The Integra Titanium Bone Wedge is available in 15 different pre-shaped anatomical sizes, to accommodate various skeletal deformities in the foot.

“We’re very pleased that we can now offer surgeons another option to complete our flatfoot correction portfolio,” said Robert Paltridge, president of Integra’s Extremity Reconstruction unit. “Our Titanium Bone Wedges provide more stability over allograft wedges. Additionally, our extensive line of pre-shaped bone wedge implants does not require custom shaping, which helps reduce surgical time.”

Plainsboro, N.J.-based Integra LifeSciences, makes technology for orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.