The FDA has granted 510(k) clearance to OsteoMed, LLC to market its ExtremiFuse device for the correction of hammertoe deformities. Company officials estimate that approximately 60 million people suffer from this toe deformity and 550, 000 surgeries are performed annually to correct it. Hammertoe occurs most frequently in the second, third and fourth toes, according to a company official.
OsteoMed Marketing New Hammertoe Remedy
1 min read Premium comments
Secondary
OsteoMed is offering ExtremiFuse in both a straight and 10 degree solution.Officials say that these self-drilling, threaded implants provide for easy insertion. They can be placed without using a drill and the shape and design reduce the force need to fully place the implant. ExtremiFuse is OsteoMed’s latest product release and officials state that it complements the firm’s existing comprehensive lower extremity product portfolio.
“Our commitment to providing improved patient outcomes through the design, manufacture and service of high quality, innovative and cost-effective surgical products continues with this exciting new product offering, ” stated David Kelly, vice president of OsteoMed’s Small Bone Orthopedic Division. The company was founded in 1990 and is located in Addison, Texas.
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.