| K-number | K250315 |
| Device name | RONAVIS FX (FX-001) |
| Applicant | AIRS, Inc. |
| Product code | HTY |
| Device class | Class II |
| Decision date | Aug 1, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The RONAVIS-FX is an external fixation pin made of SUS316L stainless steel, consisting of a sleeve, inner pin, and anchor head. It is inserted through the skin into bone to apply traction and temporarily stabilize bone fragments for less than 24 hours during orthopedic and extremity procedures.
The device uses 316L stainless steel construction and is configured as a unicortical bone pin with three integrated components (sleeve, inner pin, anchor head). It is provided non-sterilized and must be sterilized by the user before use and is prohibited from reuse.
Mechanical testing per ASTM F543 and ASTM F1541 for torsional strength, axial pull-out strength, and bending strength. Biocompatibility evaluated per ISO 10993-1, 10993-5, 10993-10, 10993-11, and 10993-23 for cytotoxicity, sensitization, irritation, and systemic toxicity.
The RONAVIS-FX is substantially equivalent because it shares identical intended use (temporary bone stabilization), comparable material composition (316L stainless steel), and similar technological characteristics to the predicate Apex Pins. No new safety or performance issues are raised compared to the predicate device, and the device demonstrates adequate mechanical strength and biocompatibility.
View the full FDA submission: accessdata.fda.gov