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MẌ Orthopedics receives FDA clearance for nitinol compression screw
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MẌ Orthopedics Corp. announced it has received FDA 510(k) clearance for the dynaMẌ Nitinol Compression Screw.
According to a company press release, the dynaMẌ Nitinol Compression Screw utilizes the super-elastic properties of nitinol to provide higher levels of compression compared with contemporary bone screws. The dynaMẌ Nitinol Compression Screw is stretched and held in an elongated position with an internal pin during the manufacturing process. Following implantation, the internal pin is removed and the crew attempts to shorten and return to its original upstretched length. This process reportedly provides compression to the patient’s bone.
“Bone is a living material that remodels with altering stress levels, changing shape and mechanical properties. The dynamic healing process warrants a dynamic implant material,” Matthew Fonte, PhD, founder and president of MẌ Orthopedics Corp., said in the release. “The dynaMẌ Nitinol Compression Screw represents the next generation of screw fixation technology as it is engineered to change shape in vivo, enhancing fracture reduction while applying controlled compression to the fracture site.”
References:
www.mxortho.com/products/compression_screws/
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm