FDA Clearance and Launch of New Osteotomy Wedges from Integra

Integra LifeSciences Holdings Corporation has announced the FDA 510(k) clearance and commercial introduction of the Integra® Titanium Bone Wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle.

Background

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 composed 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.

Integra says the new system will be featured at the American College of Foot and Ankle Surgeons (ACFAS) 72nd Annual Scientific Conference, February 27 – March 2, 2014, in Orlando, Florida.

Company comments

“We’re very pleased that we can now offer surgeons another option to complete our flatfoot correction portfolio,” said Robert Paltridge, President, Extremity Reconstruction. “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.”

Source: Integra Lifesciences Holdings Corporation, Globe Newswire

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