Englewood Cliffs, NJ – GLW, Inc. (“GLW Medical” or the “Company”), a medical technology company focused on advancing orthopedic extremity and trauma surgery, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its upcoming Apollo Ankle Fracture (AFX) Plating System, a novel portfolio of see-through, “ortholucent” bone plates and screws used for orthopedic ankle fracture surgery. Expected to be in limited market release during the second half of 2022, it will complement GLW Medical’s Creed Ortholucent Implant portfolio of headless and headed compression screws and it further expands Company’s product offering in the foot and ankle space.
The Apollo AFX plating system is a streamlined, multi-component platform featuring a distinctive, proprietary plate composite consisting of an additive manufactured titanium shell injection molded with a novel Solvay Zeniva® PEEK polymer. The intelligently designed implants come with a selection of 26 unique plate options from 6 plate families.
Thomas H. Lee, MD, Chief Medical Officer of Carbon22, said “This next-generation engineering of Apollo AFX plates is an important milestone for GLW Medical. Our team has spent a tremendous amount of effort with our Carbon22 consortium, a select group of orthopedic and podiatric surgeons, to develop a system that includes several groundbreaking components; all working together to make ankle plating simpler and more reproducible. The Apollo AFX Plating System will be an important platform as we continue to develop GLW Medical’s product portfolio. The Company has created a bridge between materials science and device design, positively transforming the manufacturing process and cost-effectiveness, while maintaining, or improving patient outcomes.”
GLW Medical’s patent pending ortholucent manufacturing technology offers several key benefits, including radio-transparency. Alan Ng, DPM, FACFAS of Advanced Orthopedic & Sports Medicine Specialists in Denver, CO noted, “While using medical imaging (both during and after surgery), the radio-translucent properties of these ankle fracture plates greatly improve visualization of bony structures. By being able to see through the implants down to the fracture site, these plates can vastly improve visibility during post-operative healing.”
The hybrid TI-PEEK plate interface minimizes the risk of plate and screw ”cold-welding” that has been seen with other plating systems currently on the market. Additionally, the hybrid TI-PEEK construction of the plates allow for superior contouring to accommodate complex anatomy.
“The Apollo AFX plating system represents a paradigm shift in orthopedic device implants and provides a distinguishing clinical advantage over traditional metal-only-implants by drastically improving intraoperative and postoperative visualization of bones and joint spaces,” commented Kevin Lutta, MD, of OrthoVirginia in Arlington, VA. Adding “The system’s well-designed details give surgeons the most advanced implant technology on the market to date.”
ABOUT GLW MEDICAL
GLW Medical is a medical technology company focused on advancing orthopedic extremity and trauma surgery. By combining traditional and minimally invasive techniques with advanced manufacturing, including 3D printing and proprietary ortholucent technology, GLW Medical develops implants and instruments intended to support surgical efficiency and facilitate patient recovery.