RTI Surgical Foot Compression Plate System Cleared
Orthopedics This Week reports RTI Surgical Inc. has received FDA 510(k) clearance for its Dynamic Active Compression (DAC) Plate system. The system with proprietary compression technology, is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, osteotomies, arthrodeses and reconstruction of small bones of the foot.
The primary differences in the design of the DAC system from predicate devices are Nitinol wires which create compression across the fracture as the release pins are removed during surgery. The system will be labeled as magnetic resonance, conditional on performance testing submitted for support of the claim. HSS foot and ankle surgeon and RTI consultant Constantine A. Demetracopoulos, MD, said the plate "is designed to improve fusion procedures in the foot by combining the rigid stability of a plate with Nitinol's ability to provide continuous compression and ensure apposition of the bony surfaces during healing."
Read the full article at ryortho.com.