FDA approves Inion's biodegradable screw for ACL repair

By Lisa Kerner

Erie, Pa., March 20 - Inion Oy said it received Food and Drug Administration 501(k) clearance for its Inion Hexalon 6 mm Interference Screw for cruciate ligament repair applications.

Anterior cruciate ligament (ACL) tears are the most common injury to the knee, often resulting from sporting activities. A newer technique for ACL repair, the double-bundle technique, uses two ligaments and more closely restores knee function, according to a company news release.

Inion said its Hexalon biodegradable interference screws allow surgeons to use the double-bundle technique and a smaller screw, without compromising strength of implant and fixation.

"We are very happy to receive another FDA clearance to expand our product range in the sports medicine field," chief executive officer Dr. Auvo Kaikkonen said in the release.

"The new 6 mm 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."

Inion, a Tampere, Finland-based company, specializes in the development of biodegradable medical implants.

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