The FDA has given 501(k) clearance to the Integra(R) Titanium Bone Wedges, designed for osteotomies in the foot and ankle; procedures in which surgeons cut a bone to shorten, lengthen, or change its alignment to help correct deformities. It is also performed to correct a bunion or bone that has healed crookedly following a fracture, as well as correct a coxa vara (a deformity of the hip, on which the angle between the head and the shaft of the femur is reduced to less than 120 degrees), genu valgum (knock knees), and genu varum (bowed legs). It is also one method used to relieve pain in arthritis, especially of the hip and knee, although most older patients are now opting for joint replacement instead.
The bone wedges are designed to provide by providing a “scaffold for bone growth, as well as biologic stability and structural,” according to the company, which went on to explain that “ancillary plates are then used to hold bone graft material in place and prevent it from expulsion.”
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," stated 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."
The system will be featured at the American College of Foot and Ankle Surgeons (ACFAS) 72nd Annual Scientific Conference, today (February 27) thru March 2, 2014, in Orlando, FL.