| K-number | K254182 |
| Device name | Aster |
| Applicant | Osteonic Co., Ltd. |
| Product code | KWQ |
| Device class | Class II |
| Decision date | Feb 26, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3060 |
The ASTER is an anterior cervical plate system made from titanium alloy used to provide anterior fixation for cervical fusion procedures. It consists of various plates and screws with locking caps to prevent screw back-out, and is available in multiple plate lengths and screw configurations to accommodate patient anatomy.
Based on comparison with the predicate devices, the ASTER shares the same intended use and technological characteristics. The device is an anterior cervical plating system with bone screws for fixation, made from titanium alloy per ASTM F136.
Mechanical performance testing was performed using ASTM F1717, which includes static compression bending, static torsion, and dynamic compression bending fatigue testing applicable to spinal plate systems.
The device has demonstrated substantial equivalence through non-clinical performance testing meeting applicable acceptance criteria and showing mechanical performance comparable to the predicate device. The bench testing results confirm the subject device is as safe and effective as the legally marketed predicate device for its intended use.
View the full FDA submission: accessdata.fda.gov