Dallen Medical Inc. is announcing the receipt of 510(k) clearance from the FDA for its Tensyn Plug. According to the company, this is the first adjustable orthopedic fixation device. The company indicates that this is an improvement over its prior product—the Tensyn Band—because it offers a lower profile, knotless fixation implant.
510(k) for Dallen Medical
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The Tensyn Plug allows surgeons to adjust the implant prior to locking into place; it can be adjusted by loosening the screw cap and sliding the cap back before re-positioning and locking the screw cap.
The February 17, 2015 news release notes: “The Tensyn Plug is now cleared for syndesmosis, AC/CC joint stabilization, mid-foot (Lisfranc), lower foot, and wrist and hand repair. The device incorporates the company’s proprietary, Tensyn knotless banding technology for stabilized fixation of soft tissue in the extremities while allowing physiologically natural movement of those joints not available with rigid screw fixation.”
The product uses a wide suture band to distribute fixation forces more broadly than alternative products. Dallen indicates that this broader distribution of fixation pressure is easier on the surgeon’s hands and, therefore, easier to lock into place.
“We have evolved our Tensyn Band technology one step further, providing an implant with virtually unlimited application across small extremities for fixation with or without plating, ” said David Mills, Chief Executive Officer of Dallen Medical. “In addition, the company will be making another submission to the FDA shortly for the expanded use of the Tensyn Plug in the knee and hip.”
Mills told OTW, “The most interesting part of the product development process is learning the unforeseen advantages and attributes of a product. In the case of the Tensyn Plug, we discovered that the ease of adjustability was an even greater benefit than initially anticipated. In fact, we were surprised at the extent of dissatisfaction among surgeons for existing fixation devices that they told us were complicated to use and hurt their hands.”
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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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