Met One Technologies, LLC · Class II · Cleared Feb 12, 2026
| K-number | K251732 |
| Device name | Wrist Fracture System |
| Applicant | Met One Technologies, LLC |
| Product code | HRS |
| Device class | Class II |
| Decision date | Feb 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Wrist Fracture System is an implant system for repairing radius fractures, consisting of titanium fracture plates, titanium bone screws, k-wires, and surgical instruments. The Distal Radius Plate is indicated for fixation of fractures, osteotomies, and non-unions of the distal radius, while the Dorsal Bridge Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.
The device has similar technological characteristics, surgical approach, materials, range of sizes, design, and principles of operation as the predicate devices. It includes titanium plates (multiple grades and production processes including grade 23 Ti-6Al-4V ELI, grade 4 CP Ti, and additively manufactured variants), 2.4 mm and 3.0 mm titanium screws with self-locking mechanisms, stainless steel or titanium k-wires, and reusable surgical instruments.
ASTM F382 Static Four-point Bend Testing, ASTM F382 Dynamic Four-point Bend Testing, ASTM F543 Torsional Properties, and ASTM F543 Driving/Removal Torque. Materials conform to ASTM F136, ASTM F67, ASTM F3001, ASTM F138, and related standards.
The Wrist Fracture System has identical or similar indications for use as the primary and additional predicate devices (APTUS Wrist 2.5 System, Trimed Wrist Fixation System 3, SkyOPS Orthopedic Plate System, and Acumed Wrist Plating System). Mechanical testing demonstrated worst-case constructs were substantially equivalent to legally marketed devices, and any differences in technological characteristics do not raise different questions of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov