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Mainpage / News Archive / News 2006 / 510(k) Clearance received for Inion Hexalon
 

Inion Expands Biodegradable Medical Implant Product Ranges in USA

 

510(k) Clearance received for Inion Hexalon™

6mm Interference Screws

                                                                                                

Tampere, Finland and Takeley, UK. 21 March 2006…Inion [LSE: IIN.L], a company focused on the development of novel biodegradable medical implants, has received FDA 510(k) clearance for the Inion Hexalon™ 6mm Interference Screw for cruciate ligament repair applications.

 Anterior cruciate ligament (ACL) tears are the most common injury to the knee joint with approximately 250,000 tears occurring each year in the US alone, frequently resulting from sporting activities. Historically these have been repaired using a single bundle of ligament to replace the torn ACL. More recent research has shown that this technique does not completely restore normal knee function. A new technique has been developed, called the “double-bundle technique”, which uses two ligaments and restores more closely the function of the knee.

 Inion Hexalon™ biodegradable interference screws are made from a specific Inion OPTIMA™ blend that enables surgeons performing the double-bundle technique for ACL repair to use a smaller fixation screw without compromising strength of implant and fixation.

 Dr Auvo Kaikkonen, CEO of Inion commented, “We are very happy to receive another FDA clearance to expand our product range in the sports medicine field. The new 6mm Hexalon screw will be an addition to our existing range and enable us to service the increased use of the double-bundle approach for ACL reconstructions.”

 -Ends-

 For further information, please contact:

 Inion Oy    

Dr Auvo Kaikkonen, Chief Executive Officer

Tim Hirst, Corporate Communications

 Tel: +358 3 230 6600

Tel: +44 (0)1279 874 222

Citigate Dewe Rogerson

Mark Swallow / Helena Podd

 Tel: +44 (0)207 638 9571

 

About Inion (www.inion.com)

Inion Oy is a Finnish company that specializes in the development of biodegradable medical implants.

 

The Inion core expertise and technology lies in the design and manufacture of innovative biodegradable plates, screws, pins and membranes that are used to enhance the healing of skeletal injuries (bone and soft tissue), such as those caused by trauma or by reconstructive surgery. Inion implants are made from its proprietary Inion Optima™ family of biomaterials, with properties tailored for specific surgical applications, in terms of strength, flexibility and rate of degradation.

 

Inion has developed and launched products in five strategic business areas – cranio-maxillofacial surgery, orthopaedic trauma, sports medicine, dental surgery and most recently in the spinal implant area – in more than 40 countries worldwide.

 

Inion was incorporated in early 2000 by an international team of experts in biodegradable materials and their clinical applications, and listed on the Official List of the UK Listing Authority in December 2004. The Company’s has operations in the UK, R&D and production facilities in Tampere, Finland, and a US office in Oklahoma City, OK.

 


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