In short
Back in September we covered the news that German trauma device company aap Implantate AG had gained FDA 510(k) clearance to market its small fragment plating set. Now, as predicted at the time, the company has announced that the first six systems of the Loqteq® Trauma Plating family of products has also received the agency’s nod.
Background
Loqteq® is an anatomic orthopaedic trauma plating system that enables locking and compression with a single hole, enhancing ease of use for surgeons and improving operating room efficiency.
The cleared Loqteq® products include six plating systems to address orthopaedic trauma injuries for small and large bone fragments, arms (proximal humerus), and legs (distal femur, proximal lateral and distal medial tibia), providing surgeons with state-of-the-art anatomical plates for a variety of muskuloskeletal regions. The system features a unique threaded screw head design to enable single-step compression and angular stability. It offers defined, adjustable compression from 0 mm to 2 mm, with automatic safe locking after full compression. The first six Loqteq® systems are expected to be commercially available in the U.S. in early 2013.
Biense Visser, Chief Executive Officer of aap Implantate AG, said, “With the first series of Loqteq® products cleared in the U.S., we are positioned to execute our commercial strategy for this significant market for our trauma business. Loqteq® has been well-received by the medical community in Europe, and we anticipate similarly strong adoption in the U.S. as the system is made available. Given our high confidence in the surgeon and patient benefits of the technology, we are continuing to invest in the product family, with the expected launch of additional six Loqteq® systems that will round out the portfolio planned for 2013.”
Physician comments
Jörg Schmidt, MD, Chief of the Department of Orthopaedics, Trauma, Hand and Reconstructive Surgery at Asklepios Klinik Weissenfels in Weissenfels, Germany, said, “The Loqteq® Compression Technology offers a great benefit especially in elderly patients with osteoporotic bones. The possibility of a secure fixation and compression is a huge gain in the compression osteosyntheses. Loqteq® has a perfect anatomical fit to nearly every bone.”
Prof. Dr. Gerrit Oedekoven, MD, Chief of Trauma & Orthopaedics at St. Elisabeth Hospital, a Teaching Hospital of the Technical University Munich, in Straubing, Germany, said, “The Loqteq® system is a combination of technological advanced anatomical plates and familiar AO operation techniques. The plates fit perfectly each time. The instrumentation is easy to understand and very functional.”
Regulatory status/Availability
The Loqteq® system, manufactured in Germany, is currently marketed internationally in the CE region. Worldwide launch of an additional six Loqteq® systems is planned for 2013. For these additional six systems, the completion of the CE-conformity assessment procedures is expected for the first quarter of 2013 and the FDA-clearance latest in the third quarter of 2013.
Source: aap Implantate AG.
published: December 11, 2012 in: Approval/Clearance, Trauma