Trauma and biomaterials company aap Implantate AG. has announced that it has received 510(k) clearance from the U.S FDA for the small fragment plating line of its Loqteq® product family. Loqteq® is described as an anatomic, angle-stable orthopaedic trauma plating system that enables lock and compression with a single hole, which enhances ease of use for surgeons. aap says the system also provides surgeons with variable compression from 0 mm to 2 mm.
German orthopaedic device company aap Implantate AG, has been around for over 20 years now with its ongoing focus being on orthopaedics, most specifically its impressive trauma nail lines.
This 510(k) cleared small fragment system consists of a straight plate, a reconstruction plate, a one-third tubular plate and Loqteq cortical screws. The 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. aap expects to announce the worldwide launch of an additional eight Loqteq systems in 2013.
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.”
Source: aap Implantate AG.