DeGen Medical, Inc., a Florence, South Carolina-based medical device company has received FDA clearance for its CONNECT-L™ Transverse Connector to be used with its F1 Modular Pedicle Screw System (MPS). The F1 MPS™ System is intended to provide immobilization and stabilization of the posterior non-cervical spine.
FDA Clears DeGen Medical’s Connector
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The company describes its product as being small, with a low profile and easy to use. According to the press release, the rod-to-rod connection provides improved construct stability and rigid fixation to the posterior spinal system. The system includes fixed and variable sizes for posterior thoraco-lumbar-sacral spine surgeries. Company officials point out that the variable option allows for additional maneuverability for complex spinal stabilization procedures.
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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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