GM Dos Reis Industria e Comercio Ltda. · Class II · Cleared Mar 17, 2026
| K-number | K260390 |
| Device name | Super Upper Limbs Versalock Plating System |
| Applicant | GM Dos Reis Industria e Comercio Ltda. |
| Product code | HRS |
| Device class | Class II |
| Decision date | Mar 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Super Upper Limbs Versalock Plating System is a bone fixation device consisting of metallic plates and screws made from titanium alloy (Ti6Al4V) and pure titanium. It is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand, wrist, and forearm, with particular suitability for treating fractures in osteopenic bone.
The device uses titanium alloy (Ti6Al4V per ASTM F136) and pure titanium (ASTM F67) construction. Plates range in thickness from 0.6 to 4.0 mm and screws range in diameter from 2.0 to 3.5 mm. The subject device shares equivalent design characteristics, physical dimensions, material composition, and anatomical region coverage with its predicate devices, with no differences that raise new safety or efficacy questions.
Mechanical testing was performed according to ASTM F382 and ASTM F543 standards, with all tests confirming the product met predetermined acceptance criteria.
View the full FDA submission: accessdata.fda.gov