Spineart SA · Class II · Cleared Apr 9, 2026
| K-number | K254158 |
| Device name | SPINEART Navigation Instrument System |
| Applicant | Spineart SA |
| Product code | OLO |
| Device class | Class II |
| Decision date | Apr 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The SPINEART Navigation Instrument System is a set of reusable surgical instruments (screwdrivers, taps, probes, drills) made of stainless steel for use during spinal surgery. These instruments assist surgeons in precisely locating anatomical structures and placing SPINEART screws in open or minimally invasive procedures, using navigation guidance from compatible systems like Medtronic StealthStation or Brainlab Spine & Trauma Navigation.
The subject device is a product line extension adding taps, screwdrivers, and probes for the PERLA-1 Posterior Thoraco-Lumbar Fixation System. The material, design features, and sizing of the line extension instruments were developed with the same specifications as the predicate devices, with no significant differences in design or performance characteristics.
ASTM F899 (stainless steel material specification). Not stated in this summary: specific ISO standards for testing or performance validation beyond reference to geometric comparison with predicates.
Substantial equivalence is established because the subject product line extension has identical indications for use, the same material composition and design specifications as multiple legally marketed predicates, and a geometric comparison demonstrated safety and efficacy for accuracy performance, requiring no additional non-clinical or clinical testing.
View the full FDA submission: accessdata.fda.gov