The FDA has awarded 510(k) clearance for the Novel Axis Charcot Fixation System, made by Extremity Medical, LLC of Parsippany, New Jersey.
Novel Foot Fixation System Awarded 510(k) Clearance
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According to the manufacturer, the system is a comprehensive axial fixation system for which provides biomechanical advantages allowing for “super construct” type fixation.
The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm is indicated for reconstruction procedures, nonunions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthropathy.
Matt Lyons, chairman and CEO of Extremity Medical commented, “Extremity Medical’s goal has been to continue to develop innovative products that will significantly impact the extremity surgeon’s ability to treat challenging patient conditions.”
“The Axis Charcot Fixation System, along with the recent release of BioFuse (a next generation live‐cell bone graft), provides significant advancements in the treatment of these patients.”
Currently, Extremity Medical has 16 products released globally which include specialized fixation and advanced arthroplasty systems for the distal lower and upper extremities.
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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.
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