Carlsmed, Inc. · Class II · Cleared Jan 6, 2026
| K-number | K252894 |
| Device name | aprevo® cervical interbody system |
| Applicant | Carlsmed, Inc. |
| Product code | ODP |
| Device class | Class II |
| Decision date | Jan 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The aprevo® cervical interbody system is a personalized, additively manufactured titanium interbody fusion device for stabilizing the cervical spine (C2-T1) in patients with disc disease, instability, trauma, deformity, spondylotic myelopathy, stenosis, or failed previous fusion. It comes in two configurations: the ACDF version (requiring supplemental fixation) and the ACDF-X version (usable as a standalone system with accompanying screws, except for certain deformity cases).
The device is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 with an aperture for bone graft packing. Accompanying screws are made from titanium alloy per ASTM F136. Associated instruments are stainless steel per ASTM A564. The individualized design is developed using patient radiological images to create patient-specific features.
ASTM F2077 (static and dynamic axial compression, compression shear, and torsion testing); ASTM F2267 (subsidence testing); ASTM F3001 (titanium alloy specification); ASTM F136 (titanium alloy specification); ASTM A564 (stainless steel specification).
The aprevo® cervical interbody system demonstrates substantial equivalence to predicate devices through comparison of intended use, operating principle, design, components, materials, biocompatibility, manufacturing, packaging, labeling, sterility, and non-clinical testing. Mechanical performance testing showed substantially equivalent results to predicate devices across compression, shear, torsion, and subsidence tests.
View the full FDA submission: accessdata.fda.gov