Medos International SARL · Class II · Cleared Oct 21, 2025
| K-number | K253249 |
| Device name | TriALTIS Spine System |
| Applicant | Medos International SARL |
| Product code | NKB |
| Device class | Class II |
| Decision date | Oct 21, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
The TriALTIS™ Spine System is a posterior spinal fixation system composed of titanium alloy bone anchors (screws), longitudinal rods, and connectors that provide immobilization and stabilization of the thoracic, lumbar, and sacral spine (T1-S2) as an adjunct to fusion. It is indicated for treatment of various spinal conditions including degenerative disc disease, spondylolisthesis, trauma, stenosis, deformities, tumor, pseudarthrosis, and failed previous fusion in skeletally mature patients, with additional pediatric indications for progressive spinal deformities.
The TriALTIS™ Spine System implants are comprised of titanium alloy conforming to ASTM F136 and nitinol conforming to ASTM F2063. The system uses pedicle and nonpedicle fixation mechanisms with multiple components including bone anchors, longitudinal rods, set screws, and connectors. Implants may be provided in sterile or non-sterile form. Fenestrated screw variants are available for use with CONFIDENCE™ High Viscosity Spinal Cement.
Not stated in this summary. The document references ASTM F136 (titanium alloy) and ASTM F2063 (nitinol) as material standards but does not detail specific test methods or performance standards used for substantial equivalence evaluation.
The TriALTIS™ Spine System has the same indications for use as the previously cleared TriALTIS™ Spine System predicate device. Evaluation of the device's intended use, technological characteristics, and performance data demonstrates substantial equivalence in safety and effectiveness profile compared to predicate systems including EXPEDIUM® Spine System and earlier TriALTIS™ generations.
View the full FDA submission: accessdata.fda.gov