Spine Innovation, LLC · Class II · Cleared Jan 8, 2026
| K-number | K253266 |
| Device name | Titanium Interbody System |
| Applicant | Spine Innovation, LLC |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jan 8, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The Titanium Interbody System is an expandable spinal fusion device used to stabilize and promote fusion of the spine in skeletally mature patients with degenerative disc disease at one or two contiguous lumbar levels (L2-S1). It is used with autograft and supplemental fixation after at least six months of conservative treatment.
The modification from the predicate device (K153356) involves a change in implant material from the original material to porous titanium (ASTM F67) and titanium alloys (Ti-6Al-4V per ASTM F1472 and F136), and a change in packaging and sterilization from bulk implant packaging to individual device sterile packaging. Intended use, implant design, and size availability remain unchanged.
Static and Dynamic Axial Compression per ASTM F2077-18; Static and Dynamic Shear Compression per ASTM F2077-18; Static Torsion Test per ASTM F2077-18; Subsidence per ASTM F2267-04(2018).
Performance testing of the Titanium Interbody System demonstrated substantial equivalence in performance compared to the legally marketed predicate device. The material and packaging changes do not alter the intended use, design, or size availability of the implant.
View the full FDA submission: accessdata.fda.gov