| K-number | K250155 |
| Device name | Xpert Knee |
| Applicant | Newclip Technics |
| Product code | HRS |
| Device class | Class II |
| Decision date | Apr 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Xpert Knee is a range of titanium plates and screws designed to fixate fractures, non-unions, and malunions of the proximal tibia in adult patients. The implants are provided either sterile (via gamma sterilization) or non-sterile for sterilization by healthcare professionals before surgical use.
The Xpert Knee uses CP Titanium grade 4 for plates (ASTM F67, ISO 5832-2) and Titanium alloy Ti-6Al-4V ELI for screws (ASTM F136, ISO 5832-3). The device has the same material composition, shape, operating principles, and dimensions as the predicate devices, with substantially equivalent design and sizing.
ASTM F382 was used for comparative static and dynamic testing of the plates. ASTM F543 was used for pullout strength analysis and comparative torsional testing of the screws.
The Xpert Knee is substantially equivalent to the DePuy Synthes 3.5 mm LCP Proximal Tibia Plate System predicate because it uses identical materials, has the same indication for use (fixation of proximal tibia fractures, non-unions, and malunions in adults), maintains the same design and operating principles, and demonstrates equivalent mechanical performance through comparative engineering testing per established ASTM standards.
View the full FDA submission: accessdata.fda.gov