Ruthless Spine RJB

The Ruthless Spine RJB is an intraoperative surgical angle measurement tool that attaches to surgical instruments to measure their angle relative to a vertical plumb line in line with gravity. It measures axial and sagittal angles and is indicated for use during lumbosacral pedicle screw implantation as an adjunct to fluoroscopy or intraoperative x-ray. The device does not provide surgical guidance or navigation and is not intended to replace surgeon judgment.

The subject device has identical indications for use, classification, regulation, and product code as the predicate. Both measure angles in two planes relative to vertical gravity using Bluetooth Low Energy connectivity to a tablet computer. The subject adds single-use disposable instruments (plastic handles, probes, and MPV7 Jamshidi needles) and includes a cosmetic software update; the predicate provided only reusable handles and probes. The subject uses stainless steel, aluminum, and PARA materials versus predicate's stainless steel and aluminum.

Not stated in this summary. The document references sterilization validation (ethylene oxide, gamma radiation, steam), packaging validation for 2-year shelf life, biocompatibility evaluation, and angle measurement accuracy testing, but does not cite specific ISO, IEC, or ASTM standards.

Substantial equivalence is established because the subject device has identical intended use, indications for use, technological design (two-plane angle measurement relative to gravity), and core functionality as the predicate. The additions of disposable instrument variants and a cosmetic software update do not alter the device's fundamental performance or safety profile. Non-clinical testing demonstrates equivalent angle measurement accuracy, sterilization efficacy (SAL 10⁻⁶), and packaging integrity. Biocompatibility is established through material and process equivalence to the previously cleared predicate, with PARA material addition representing a minor variation in the same material category.