The U.S. Food and Drug Administration has granted 510(k) clearance to Conventus Orthopaedics, Inc. for its Conventus Orthopaedics Cage PR (Proximal Radius) System—number three in the series. According to the press release, the system is designed to be a means of addressing fractures of the head and neck.
FDA Clears Conventus’ Third Cage
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As explained in the press release, the system takes advantage of the shape memory properties of nitinol and expands within the bone creating stable fixation and preventing the collapse of the fracture repair.
The new Conventus Cage, according to company officials, is similar to the first two products. This third Conventus Cage PR creates a rigid substrate designed to self-expand within the bone to avoid interference with soft tissues and ultimately improve upon pronation and supination.
" data-large-file="https://i0.wp.com/ryortho.com/wp-content/uploads/2015/09/FDA_ConventusOrthopaedicsCage_WEB2.jpg?fit=730%2C233&ssl=1" src="https://i0.wp.com/ryortho.com/wp-content/uploads/2015/09/FDA_ConventusOrthopaedicsCage_WEB2.jpg?resize=730%2C233&ssl=1" alt="Courtesy of Conventus, Inc." width="730" height="233">Courtesy of Conventus, Inc.
“The implant is designed to address important limitations of conventional approaches to radial head and neck repairs while allowing for preservation of the bony anatomy and preserving future treatment options, ” company officials explained.
Paul Buckman, Conventus President and CEO said, “The approval of this additional indication reflects our commitment to provide more innovative solutions and options for surgeons working to repair orthopedic fractures throughout the body. Our overall goal is to provide a complete platform technology enabling surgeons to treat all trauma and fracture repairs from a 3-dimensional approach.”
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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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