Inspired Spine Gains FDA Clearance for Trident SI Joint Screw

By Julie A. Vetalice

Inspired Spine Gains FDA Clearance for Trident SI Joint Screw

Inspired Spine was granted FDA 510(k) clearance to market Trident Sacroiliac (SI) Joint Screw, designed to improve procedure efficiency resulting in surgery durations less than 15 minutes.

The system employs one main screw and two integrated side screws to deliver three distinct screw approaches into a single trajectory. Trident's integrated delivery and implant system comprises a multi-use kit with a limited number of instruments, replacing multiple component instrument trays currently employed by other SI Fusion systems.

Its main screw delivery sleeve provides a targeting guide for side screw delivery, improving procedure efficiency and optimizing imaging requirements. The single incision and corresponding preplanned fixed trajectory decreases required procedure time and radiation exposure. The Trident SI screw design includes self-tapping graft collection flutes which reduce the need for additional biologic while delivering bone graft.

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory