Inspired Spine has announced that its Trident SI Joint Screw System, for use in the sacroiliac (SI) joint, has received 510(k) clearance from the US Food and Drug Administration (FDA). The product is manufactured by Advanced Research Medical (ARM).
According to a company press release, this new SI Joint fusion system employs one main screw and two integrated side screws to deliver three distinct screw approaches into a single trajectory. The Trident’s integrated delivery and implant system consists of a streamlined multi-use kit, possessing only a handful of instruments which simplifies the procedural steps. This simplified kit replaces the multiple component instrument trays currently employed by other SI Fusion systems by combining the functionality of a traditional set and multiple instruments into a single screw.
Inspired Spine states that its main screw delivery sleeve provides a targeting guide for side screw delivery, improving procedure efficiency and optimising imaging requirements. The single incision and corresponding pre-planned fixed trajectory substantially decrease required procedure time and radiation exposure. The system design includes self-tapping graft collection flutes which reduce the need for additional biologic, while delivering the advantage of autologous bone graft.
The company further claim that limiting time spent in the operating room brings many benefits to surgeons and patients. This advanced technology limits the number of tools the surgeon needs to use for the procedure, ultimately reducing prep-time and allowing the surgeon to operate more efficiently. This technology will take the SI Joint procedure into the future and help countless patients receive back pain relief.