Gm Dos Reis Industria E Comercio · Class II · Cleared Dec 19, 2025
| K-number | K251050 |
| Device name | Pectus Versa System |
| Applicant | Gm Dos Reis Industria E Comercio |
| Product code | HRS |
| Device class | Class II |
| Decision date | Dec 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Pectus Versa System is a minimally invasive implant system for treating pectus excavatum and other anterior chest wall deformities in adult and pediatric patients. The system uses connecting bars and stabilizers manufactured from titanium alloy to exert internal force on the chest wall, enabling repositioning of the thoracic bone structure.
The device is manufactured from titanium alloy Ti6Al4V (ASTM F136) with identical materials and equivalent design characteristics, physical dimensions, and anatomical region to the predicate devices. It features connecting bars and stabilizers for complex system assembly and minimally invasive surgical application.
Mechanical testing was performed according to ASTM F382-17, including static and fatigue tensile construct testing and static and fatigue lateral bend testing to evaluate maximum load, displacement, and runout load at 1 million cycles.
The subject device is substantially equivalent to its predicate devices because it demonstrates the same technological characteristics, intended use, indications for use, material composition, anatomical region, multiple sizes, and basic design features. Any differences are considered minor and do not raise new safety or efficacy concerns, supported by mechanical testing that confirms performance equivalence.
View the full FDA submission: accessdata.fda.gov