Press Releases

OrthoHelix Recieves FDA Clearance to Market New Mini Variable Angle Locking Screw Option

Posted on June 17, 2011

FOR IMMEDIATE RELEASE

OrthoHelix Surgical Designs, Inc: New Mini Variable Angle Locking Screw Option

Medina, Ohio June 16, 2011

OrthoHelix Surgical Designs, Inc. has received FDA clearance to market new mini variable angle locking screw option. OrthoHelix's Mini MaxLock Extreme® plates contain Tribrid™ Technology which can accommodate fixed angle locking, non-locking, and mini variable angle locking screws.  Now surgeons have all three screw options in one set and can decide intraoperatively which screw option is best for the patient’s procedure. Unlike other variable angle locking systems on the market, the Tribrid™ design does not compromise the strength of any of the locking holes.

The mini variable angle locking option utilizes a Mini PEEK ring inserted into the plate.  The Mini PEEK ring, made from PEEK-OPTIMA® polymer, by Invibio Biomaterial Solutions can be inserted into the fixed angle locking holes of all Mini MaxLock Extreme® plates. The Mini PEEK ring comes preassembled with a disposable driver. Once the 2.4mm variable angle locking screw is inserted into the Mini PEEK ring, it interfaces with the Mini PEEK ring to create a locked construct with up to 30º of conical freedom.

The DRLock Extreme® Distal Radius system, which currently has Tribrid™ Technology in the proximal screw holes, will now have the third screw option in the distal holes. The mini variable screw option can be inserted into any of the distal holes of the DRLock Extreme® Plate in addition to the 2.0mm pegs and 2.4mm non-locking and fixed angle locking screws.

PEEK-OPTIMA was chosen because of its proven biocompatibility and excellent mechanical properties.  In both static and cyclic failure testing, the variable angle locking screw construct outperforms traditional metal on metal systems.  Additionally, the option of a fixed angle locking screw is retained, allowing for maximum construct strength where appropriate.

Invibio is a global leader providing high performance biomaterials, advanced technical research and consultative solutions to medical device manufacturers across a wide range of markets. The company provides medical device manufacturers with PEEK-OPTIMA® polymer and compounds, MOTIS™ polymer, ENDOLIGN™ composite and PEEK-CLASSIX® polymer for the development of long- and short-term implantable medical devices. www.invibio.com

OrthoHelix is a Foot, Ankle, and Upper Extremity Company developing a comprehensive line of implants and instruments for use in hand and foot reconstructive surgery. OrthoHelix is dedicated to being the most responsive device maker in the orthopedic industry. We provide state of the art extremity fixation products that are reliable and easy to use. We enhance surgical outcomes of patients. Our vision is to be an orthopedic company that succeeds by listening to surgeons, giving them what they want and need for safer, faster, easier surgical procedures and improved patient outcomes. We take pride in upholding values of Integrity, Compliance, Dedication, Focus and Speed.  Surgeons Speak. We Deliver.® www.orthohelix.com

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