Life Spine expands, updates SI joint offerings with new FDA 510(k) clearance

Spinal Tech

Life Spine gained FDA approval to expand its sacroiliac joint fixation portfolio, according to a Sept. 22 announcement.

Life Spine was permitted to add a 14.5- millimeter screw to its SImpact system, which currently includes self-drilling threaded implants that are 12 millimeters and 8 millimeters in diameter.

The new size can help "fill the void of bone that is left when the old implant is removed" in revision surgeries, according to Ali Mesiwala, MD, of the Southern California Center for Neuroscience and Spine in Pomona.

Life Spine was also granted additional claims and indications for its SImpact system:

  • The implant is self-harvesting and can be used prophylactically in long-construct cases.
  • All implants are offered in overall lengths of 30 millimeters to 110 millimeters, in 5-millimeter increments.
  • The 8- millimeter lag screws now include self-drilling screw tips.

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