Osteotec Gains FDA 510(k) Clearance for ChiroKlip

By Julie A. Vetalice

Osteotec Gains FDA 510(k) Clearance for ChiroKlip

Osteotec obtained FDA 510(k) clearance to market ChiroKlip, a self-fixing disposable device that addresses protection from the protruding ends of K-wires.

ChiroKlip joins the Osteotec Silicone Finger and Concentric Bone Graft System in Ostetec's orthopedic product portfolio available in the U.S.

The butterfly-shaped clip is simple to use and protects the exposed end of the K-wire without using inefficient corks or strapping, or complicated instrumentation.

Protecting the end of the K-wire with ChiroKlip can help prevent trauma or tearing of clothing or other items. The single-use device also helps in the removal of wires by allowing optimal purchase on the wire.

"FDA registration for ChiroKlip will mean that all Osteotec own-manufactured devices can be sold in the USA, presenting a great opportunity for our export business," said Andrew Dubowski, Osteotec Commercial Director.

Product Labels: Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory