Curiteva, Inc. · Class II · Cleared Jun 18, 2025
| K-number | K250845 |
| Device name | Curiteva Porous PEEK Standalone ALIF System |
| Applicant | Curiteva, Inc. |
| Product code | OVD |
| Device class | Class II |
| Decision date | Jun 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The Curiteva Porous PEEK Standalone ALIF System is an interbody fusion device used to treat degenerative disc disease and other spinal conditions at the lumbar and thoracic spine levels. It consists of porous PEEK spacers with integrated titanium alloy screws or anchors that are inserted anteriorly between vertebrae, optionally filled with bone graft or bone void filler to facilitate spinal fusion.
The device is manufactured from implant-grade PEEK (ASTM F2026), titanium alloy (ASTM F136), and tantalum (ASTM F560), with a hydroxyapatite coating approximately 20nm thick on the spacer surfaces. It is available in multiple footprints, styles, and sizes as a single-use, sterile or non-sterile device with an open central corridor for bone graft packing and anterior fixation holes.
ASTM F2077 (static and dynamic axial compression, compression-shear), ASTM F2267 (subsidence), ASTM F1877 (particle characterization), and expulsion testing.
The device shares the same intended use (lumbar interbody fusion with anterior fixation) and similar design principles (porous PEEK spacer with integrated screw/anchor fixation) as predicate devices including Globus INDEPENDENCE MIS Spacers and Osseus PISCES-SA. Material composition, function, packaging, and sterilization methods are comparable, and non-clinical performance testing demonstrates equivalent strength and biomechanical performance for the intended indication.
View the full FDA submission: accessdata.fda.gov