aap Implantate AG Receives Initial FDA 510(k) Clearance for its LOQTEQ Trauma Plating System

Small Fragment Plating Line is First in New LOQTEQ Product Family to Receive FDA Clearance

(PresseBox) ( Berlin, )
aap Implantate AG, (XETRA: AAQ.DE), a global medical device company focused on innovative trauma products and biomaterials for the orthopaedic market, announced that it has received 510(k) clearance from the United States Food & Drug Administration (FDA) for the small fragment plating line of its LOQTEQ® product family. LOQTEQ® is an anatomic, angle-stable orthopaedic trauma plating system that enables lock and compression with a single hole, which enhances ease of use for surgeons. The LOQTEQ® system also provides surgeons with variable compression from 0 mm to 2 mm.

Biense Visser, Chief Executive Officer of aap Implantate AG, said, "This first 510(k) clearance for the LOQTEQ® system marks a major milestone in international marketing of aap's LOQTEQ® trauma portfolio and another step forward in our strategy to focus on our core business and expand outside of Europe. The LOQTEQ® system was developed from proprietary locking-compression technology, which is already patented and used in Europe. We anticipate that the rest of the LOQTEQ® product family will subsequently receive FDA clearance, providing a substantial enhancement of aap's trauma portfolio in the U.S. We are currently evaluating potential marketing partners and distribution opportunities for LOQTEQ® in the U.S. and believe it will be successful based on its innovative features."

The 510(k) cleared small fragment LOQTEQ® system consists of a straight plate, a reconstruction plate, a one-third tubular plate and LOQTEQ® cortical screws. This 510(k) clearance is one of six clearances anticipated for the LOQTEQ® portfolio, with the remaining expected to be granted in the coming weeks.

At present, six LOQTEQ® systems (small and large fragments, humerus, femur, proximal lateral and distal medial tibia) are marketed internationally in the CE region. The worldwide launch of an additional eight LOQTEQ® systems that are currently under development is planned for financial year 2013.
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