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aap Implantate AG gets 510(k) clearance for trauma plating system
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aap Implantate AG announced the FDA 510(k) clearance of the first six systems of the Loqteq Trauma Plating family of products, following the clearance of the first Loqteq product in August.
According to a company press release, Loqteq is an anatomic orthopedic trauma plating system that enables locking and compression with a single hole. It also features a threaded screw head design to enable single-step compression and angular stability and offers defined, adjustable compression from 0 mm to 2 mm, with automatic safe locking after full compression.
“With the first series of Loqteq products cleared in the United States, 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 United States as the system is made available,” Biense Visser, chief executive officer of aap Implantate AG, stated in the release. “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.”