First Ray, a start-up focused incubated and operated by Surgical Frontiers, has announced the receipt of FDA 510(k) clearance for its innovative CortiClamp System (a two-part bone screw system) for small bone fixation.
First Ray: 510(k) for CortiClamp System
2 min read Premium comments
Secondary
As indicated in the May 16, 2016 news release, “The CortiClamp System is the first bone screw system to include a second “screw head” that is attached to the distal end of the screw, providing screw heads on both ends of the screw shaft that create superior bi-cortical clamping force. The CortiClamp System also includes an innovative ‘all-in-one’ instrument that serves as a reduction clamp, drill guide, countersink guide, depth gage and implant delivery guide. This instrument eliminates several surgical procedure steps, including placement of provisional fixation, which streamlines the procedure and reduces operative time.
“The CortiClamp System will be my preferred fixation system for several of my foot and ankle procedures, including oblique osteotomies for bunion and bunionette procedures, ” states Michael Coughlin, M.D., clinical professor of orthopedic surgery, University of California, San Francisco and director of the Coughlin Foot and Ankle Clinic at Saint Alphonsus Hospital. “Distal fixation of conventional bone screws is not always reliable in these procedures. The CortiClamp System provides more confidence in the quality of my bone fixation, especially in cases where the bone is more osteopenic or osteoporotic.”
Dr. Coughlin, a member of the Scientific Advisory Board of First Ray, and an investor in First Ray, told OTW, “The best part of developing the CortiClamp System was the quality of the team and the speed of development. My collaborators on the Scientific Advisory Board are some of my most respected colleagues: Dr. Charles Salztman, Dr. Ned Amendola, Dr. Chris Coetzee, Dr. Phinit Phisitkul and Dr. Florian Nickisch. Together with the First Ray team, we went from concept to 510(k) approval faster than any other development project I have engaged. Now, the best part will be using the product clinically to provide better fixation and better outcomes for my patients.”
“In one year, the company plans to have the CortiClamp System, along with other innovative products for foot and ankle surgery, in clinical use in the U.S.”
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.