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3D Medical Concepts Announces FDA 510(k) Clearance of Innovative External Fixation Device

Date of Release: January 19, 2015

3D Medical Concepts Announces FDA 510 (k) Clearance of Innovative External Fixation Device

3D Medical Concepts, LLC. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative Vectrix™ External Fixation System. The Vectrix's unique, patented design is based off a ball collet pin clamp that allows for independent pin placement and features an optional lengthening transport component. By allowing for independent pin placement, the surgeon is able to assemble the ideal construct for each patient's injury, rather than be restricted by the fixator's design.

The Vectrix is designed to be a comprehensive solution capable of treating a multitude of long- and short-bone fractures in adult and pediatric patients. The device is applicable to both the temporary-spanning trauma and the longer term limb reconstruction markets.

Founder of 3D Medical Concepts, Harry Lee, stated, "The product is the culmination of over 18 years of external fixation design experience that combines strength, simplicity, and versatility all in one device. It was developed to address the shortcomings of existing fixators by treating a wide range of fractures throughout the body in both the trauma and limb reconstruction market."

"We designed the Vectrix to be low profile and intuitive for the surgeon," he added. "Current external fixation devices are bulky and complex and can require extensive training before they can be used in surgery, thereby reducing the likelihood of surgeons adopting new devices."

About 3D Medical Concepts

3D Medical Concepts, LLC, is a privately held medical device company focused designing, prototyping, developing, and manufacturing surgical instrumentation, primarily for orthopaedic and spinal surgery. The company brings over 20 years of experience in the medical and surgical device field, helping to provide solutions for medical device manufacturers and providers.

For more information about the Vectrix External Fixation System, please contact Josh Reardon at This email address is being protected from spambots. You need JavaScript enabled to view it. 

Contact Information:

Josh Reardon
3D Medical Concepts
1061 Morgan Park Road
Pelham, AL 35405
3dmedicalconcepts.com
Ph. (205) 987-0935
Fax. (205) 987-0936