For immediate release, September 19, 2017: PaxMed International announces FDA 510(k) clearance, on behalf of Medartis AG of Basel, Switzerland, of new plates for the APTUS® Wrist 2.5 System. This clearance adds four plate designs to expand the range of Medartis APTUS® upper extremity fixation devices. It includes two anatomic designs each for the left and right radius: Lunate Facet Plate and Distal Radius Rim Plate. The plates provide multidirectional and angular stability for fixation of intra-articular and extra-articular fractures, correction osteotomies, or arthrodeses involving the distal radius.
This marks the 25th 510(k) clearance for Medartis (22 of which were submitted by PaxMed). It also is the 196th clearance received by PaxMed and the 46th clearance for PaxMed’s Dr. Kevin Thomas.