Life Spine, Inc., a Huntley, Illinois-based medical device company, recently received 510(k) clearance from the U.S. FDA for an expansion of its SImpact sacroiliac (SI) joint fusion system to include a larger screw (14.5mm) to the current offerings of 12mm and 8mm screws. The self-drilling screws are intended to be used after removal of failed hardware in a physical space that the smaller screws would not have sufficient purchase or grip.
SI Joint Fusion Revision System Cleared by FDA
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With the increase in SI joint fusion, in part thanks to increased coverage by payers, and increased payout by the Centers for Medicare and Medicaid Services (CMS) this year, the need for revision surgeries is projected to increase.
Ali Mesiwala, M.D., a surgeon at the Southern California Center for Neuroscience and Spine, in Pomona, California, explains that “As sacroiliac fusions become more mainstream, revision surgeries are increasing due to failures of early devices and poor surgical technique. Currently revision strategies for a non-union or malpositioned implant involve removal of the prior implant, placement of new instrumentation, and addition of bone graft. A particularly challenging problem with these cases is how best to fill the void of bone that is left when the old implant is removed. The large diameter of the SImpact Revision implant allows one to fill the bone void while supplying immediate fixation to the site.”
In addition to the wider screw for revision surgery, the clearance also allows for the marketing of more length options, and the addition of a self-drilling feature for the 8mm sized lag screw. The implants can also now be used prophylactically in long construct cases. Recent studies have shown that back pain in patients with a prior lumbar fusion is more likely than not a result of SI joint dysfunction, now considered by many as a form of adjacent segment disease.
“The SImpact system is already a robust offering for SI fixation. The additions of the revision screw, updated lag screw, and the new indications are great adjuncts to the portfolio… I have performed numerous SI fixation procedures with many different implants and SImpact is the most appealing system on the market,” said Keith Maxwell, M.D., a surgeon at Southeaster Sports Medicine and Orthopedics in Asheville, North Carolina.
The company’s website already features the update SI joint fusion portfolio.
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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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