MedShape Solutions, Inc. announced today the first FDA cleared shape memory PEEK (polyaryletheretherketone) device for orthopedics using proprietary shape memory PEEK Altera(TM) material. The Morphix(TM) Suture Anchor was recently granted FDA clearance and will be released to select U.S. markets in the coming months. Over $2.5B of PEEK-based implants are sold every year in the field of orthopedics. These devices range from spinal cages to suture anchors and across all sectors of orthopedics. As a material, PEEK provides excellent benefits such as strength, radiolucency and reliability.
"PEEK Altera(TM) is a proprietary shape memory material that will allow us to develop devices that will be 'dynamic' in nature versus the current PEEK technology which is 'static'," stated Chris Fair, MedShape Solutions' COO. The Morphix(TM) Suture Anchor system design takes advantage of the shape memory material and provides the clinician with superior fixation strength both in pull out as well as improved performance under cyclic loading. "Shape memory allows us to design and develop implants that can enter a cavity or bony tunnel in one diameter and deploy them to a much larger size. This shape change can drastically improve the strength profile of the device as well as improve the delivery environment. As an example, our 3.5mm Morphix(TM) device has a greater strength profile than most 5.5mm devices currently in the market," stated Ken Gall, PhD, founder and CTO of MedShape Solutions.