| K-number | K253906 |
| Device name | Xpert Hand |
| Applicant | Newclip Technics |
| Product code | HRS |
| Device class | Class II |
| Decision date | Mar 11, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Xpert Hand is a range of metallic plates and screws designed to fix hand fractures, osteotomies, and arthrodeses in adult patients. The implants are made from CP Titanium grade 4 (plates) and Titanium alloy Ti-6Al-4V ELI (screws), and are provided either sterile or non-sterile for sterilization by healthcare professionals before use.
The Xpert Hand range has the same or similar technological characteristics to predicate devices in terms of shape, operating principles, and dimensions. Both the Xpert Hand and primary predicate (STRYKER VariAx/Profyle Hand) are available in the same titanium materials.
Engineering analysis and comparative static and dynamic tests were performed on plates according to ASTM F3437. Engineering analysis of pullout strength and comparative torsional tests were performed on screws according to ASTM F543.
The Xpert Hand is substantially equivalent to the STRYKER Hand Plating System (primary predicate K062498) and additional predicates because it shares the same indication for use, identical materials, substantially equivalent design and shape, equivalent dimensions, and non-clinical testing demonstrated equivalent performance to cleared predicates.
View the full FDA submission: accessdata.fda.gov