Alphatec Spine · Class II · Cleared Feb 3, 2025
| K-number | K241375 |
| Device name | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer |
| Applicant | Alphatec Spine |
| Product code | MAX |
| Device class | Class II |
| Decision date | Feb 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
IdentiTi and Transcend Interbody Systems are spinal fusion devices for treating degenerative disc disease, spinal stenosis, and related conditions from the cervical through sacral spine. The systems use PEEK, porous titanium, or titanium alloy spacers with internal graft apertures, designed for anterior and posterior surgical approaches, and intended for use with bone grafts or FDA-cleared bone void fillers to facilitate fusion.
The devices consist of interbody spacers manufactured from PEEK Optima LT1, porous commercial titanium (Grade 2), or titanium alloy (Ti-6Al-4V ELI), available in various heights, widths, and lordotic options. NanoTec-variant surfaces feature a 20–40 nanometer hydroxyapatite coating creating nano-scale topography. All spacers include internal graft apertures and teethed endplates for fixation and expulsion prevention.
ASTM F2077 (axial compression, compression-shear, torsion); ASTM F2267 (subsidence); ASTM F1717 (compression and torsion); ASTM F543 (torsion); ASTM F2193 (cantilever bending); ASTM F2026 (PEEK), ASTM F560 (tantalum), ASTM F67 (titanium), and ASTM F136 (titanium alloy); plus gravimetric analysis (F1714) and particulate analysis (F1877).
The devices are substantially equivalent because they have the same intended use (intervertebral body fusion via interbody spacers), indications (degenerative disc disease, stenosis, herniation), and design principles (PEEK/titanium spacers with graft apertures and teeth) as predicate devices K222028, K222973, and K203714. The NanoTec surface treatment represents an incremental modification: in vitro testing confirmed nano-scale (1–100 nm) topography enhances osteogenic differentiation in mesenchymal stem cells and osteoblasts compared to control surfaces. Since technological characteristics match predicates and the nano-surface offers only enhanced bone interaction (not a new mechanism), no additional clinical testing is required.
View the full FDA submission: accessdata.fda.gov