MedShape Receives FDA 510(k) Clearance for Morphix SP Suture Anchor

 
MedShape announced the company received 510(k) clearance from the U.S. Food and Drug Administration for its Morphix SP Suture Anchor.

Advertisement

The device features the company’s new Scoria technology, a polyetheretherketone (PEEK) material manufactured with interconnected micrometer scale surface porosity. Morphix SP is the first product in MedShape’s portfolio to leverage the Scoria technology.

 

“PEEK Scoria is an exciting new technology platform for MedShape that is backed by extensive university biomaterials research,” said Ken Gall, PhD, professor of mechanical engineering and materials science at the Georgia Institute of Technology in Atlanta and chief technology officer at MedShape. “The clearance of the Morphix SP device represents an important milestone for MedShape, reflecting the future direction of the company’s growing product portfolio. Research is ongoing to create polymer devices capable of providing both immediate mechanical strength and local surface structure-mediated biological repair without the drawbacks of complete device resorption.”

More Articles on Devices:

Mazor Robotics 2013 Net Loss Shoots to $20M
Advancement in Lateral Spine Technology: Q&A with Vertebral Technologies, Inc. CEO Dr. Jeffrey Felt
EDGE Orthopaedics Receives FDA 510(k) Clearance for BITE Compression Screws

 

Advertisement

Next Up in Spinal Tech

Advertisement

Comments are closed.