StealthStation S8 Spine Software

The StealthStation S8 Spine Software v2.1 is a surgical navigation system that helps surgeons precisely locate anatomical structures during open or percutaneous spine and orthopedic procedures. It displays patient images from multiple perspectives and tracks surgical instrument position and trajectory in real-time, allowing surgeons to follow pre-planned surgical paths for procedures such as pedicle screw placement, iliosacral screw placement, and interbody device placement in adult and skeletally mature pediatric (adolescent) patients.

The subject device uses optical (infrared) tracking, the same as the predicate StealthStation S8 Spine Software v1.3. Both systems demonstrate mean positional accuracy of ≤2.0 mm and trajectory error of ≤2 degrees. Both employ identical registration features (PointMerge, SurfaceMerge, FluoroMerge, and automatic registration), planning features, display features, software interface design, programming language (C++), and compatible medical device interfaces. The primary difference is the addition of skeletally mature pediatric (adolescent) patient indications in the subject device.

Not stated in this summary.

The StealthStation S8 Spine Software v2.1 is substantially equivalent to the predicate StealthStation S8 Spine Software v1.3 (K201189) because it shares identical technological characteristics, operating principles, accuracy specifications, and all software features. The only substantive change is the expansion of indications to include skeletally mature pediatric (adolescent) patients, which was supported by a retrospective clinical literature evaluation demonstrating safety and effectiveness in that population. No changes were made to the underlying verification and validation activities.