Spineart SA · Class II · Cleared Jun 18, 2025
| K-number | K242933 |
| Device name | SPINEART Navigation Instrument System |
| Applicant | Spineart SA |
| Product code | OLO |
| Device class | Class II |
| Decision date | Jun 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The SPINEART Navigation Instrument System is a set of reusable surgical instruments designed to assist surgeons in precisely locating anatomical structures during spinal surgery using image-guided navigation. The instruments work with the Medtronic StealthStation System or Brainlab Spine & Trauma Navigation System to enable accurate screw placement in open, minimally invasive, or percutaneous spinal procedures.
The subject device adds a SPINEART Brainlab Navigation Adapter to the existing SPINEART Navigation Reusable Instrument system, enabling compatibility with the Brainlab Spine & Trauma Navigation System. The adapter connects to a NavLock Tracker interface for navigation and does not alter the design, operation, or performance characteristics of the core reusable instruments compared to predicate devices.
ASTM F2554-22 (Verification of the Navigation adapter with SPINEART Navigation reusable instruments and the full Brainlab chain of the Brainlab Spine & Trauma system). The testing protocol was adapted from this standard to verify accuracy in simulated use.
The subject device maintains identical intended use, design features, and technological characteristics to the predicate SPINEART Navigation Reusable Instrument systems (K241644, K210472, K183630). Testing demonstrated that addition of the Brainlab Navigation Adapter maintains accuracy equivalent to the predicate devices and does not raise accuracy issues when used with the Brainlab Spine & Trauma System. The adapter is merely an additional connection component that does not alter the safety or effectiveness of the core instrument system.
View the full FDA submission: accessdata.fda.gov