Arthrex, Inc. · Class II · Cleared Jan 21, 2026
| K-number | K253713 |
| Device name | Arthrex Variable Angle (VA) Proximal Tibia Plating System |
| Applicant | Arthrex, Inc. |
| Product code | HRS |
| Device class | Class II |
| Decision date | Jan 21, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Arthrex Variable Angle (VA) Proximal Tibia Plating System is designed for repairing fractures of the tibia in adult patients and those with osteopenic bone. It consists of Lateral, Medial, and Posteromedial Proximal Tibia Plates made from titanium alloy, manufactured in various lengths, and compatible with variable angle locking screws, cortical screws, and cancellous screws. The plates include K-wire holes for temporary fixation and suture holes for soft tissue management.
The Lateral and Medial Proximal Tibia Plates are offered in wider and thicker plate shafts than the primary predicate device (Smith & Nephew EVOS). The Posteromedial Proximal Tibia Plates have a thicker plate shaft than the reference predicate (Arthrex 3.5 mm Locking Compression Plates). All plates are anatomically contoured, available in multiple lengths, and accept variable angle and nominal angle locking mechanisms.
ASTM F382-24 (4-point bend testing), ASTM F136 (titanium alloy material), ISO 5832-3 (titanium alloy), ISO 11607 (packaging validation), ASTM F2052, F2119, F2182, F2213 (MRI safety testing), ANSI/AAMI ST72:2011, USP <161>, USP <85>, EP 2.6.14 (bacterial endotoxins testing).
View the full FDA submission: accessdata.fda.gov