Bonebridge AG · Class II · Cleared Apr 24, 2026
| K-number | K260228 |
| Device name | POYA 3.5mm Medial Proximal Tibia System |
| Applicant | Bonebridge AG |
| Product code | HRS |
| Device class | Class II |
| Decision date | Apr 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The POYA 3.5mm Medial Proximal Tibia System is a metallic bone fixation plate designed for adult patients with various types of medial tibia plateau fractures, including metaphyseal, split-type, and depression fractures. It is also used to fix osteopenic bone and treat nonunions and malunions of the medial proximal tibia, with longer variants indicated for fractures extending to the tibial shaft.
The device consists of stainless steel plates (ISO 5832-1, ASTM F138/F139) with titanium inlay clips (ASTM F67) and stainless steel screws. It shares the same design characteristics as predicates including screw holes for both locking and non-locking screws, encompasses the same range of physical dimensions, and is compatible with screws from the primary predicate device. All materials are biocompatible, corrosion-resistant, and nontoxic; sterilization uses gamma irradiation or steam methods per standard protocols.
ISO 11137-2 (sterilization), ISO 17664 and ISO 17665-1 (steam sterilization), ISO 11607 and ASTM F1980 (packaging), ISO 10993 series (biocompatibility), ASTM F2052-21, ASTM F2213-17, ASTM F2182-19, and ASTM F2119-24 (MRI safety testing).
The subject device has the same intended use and similar indications, technological characteristics, and materials as its predicate devices. Non-clinical performance testing including static and dynamic mechanical testing, biocompatibility assessment, and sterilization validation demonstrated substantial equivalence to predicate devices with respect to maximum force, yield strength, construct stiffness, and other performance metrics.
View the full FDA submission: accessdata.fda.gov