4Web Medical · Class II · Cleared Apr 25, 2025
| K-number | K251117 |
| Device name | Cervical Spine Truss System (CSTS) |
| Applicant | 4Web Medical |
| Product code | OVE |
| Device class | Class II |
| Decision date | Apr 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The Cervical Spine Truss System (CSTS) is an intervertebral body fusion device indicated for skeletally mature patients with degenerative disc disease at one or two contiguous cervical spine levels (C2-T1). It uses an open architecture truss design made from Ti6Al4V alloy and is placed via anterior approach with bone graft, optionally with integrated anterior plates and screws for fixation.
The device features an open architecture truss design with hierarchical surface roughness created by 4WEB's additive manufacturing process. It comes in multiple heights, footprints, and lordotic angles. The integrated plates have rotating locking tabs to prevent screw backout and accommodate various patient anatomies.
Not stated in this summary.
The modifications to the CSTS Integrated Plate (additional configurations and sterile packaging) did not create new worst-case conditions for mechanical or MR safety testing. Because the predicate device (K231739) already underwent such testing, those results are applicable to the subject device without additional testing. The device maintains the same materials, function, and indications as the predicate, demonstrating substantial equivalence.
View the full FDA submission: accessdata.fda.gov