Toetal Solutions · Class II · Cleared Dec 29, 2025
| K-number | K253325 |
| Device name | ZipToe Hammertoe Fusion System |
| Applicant | Toetal Solutions |
| Product code | HTY |
| Device class | Class II |
| Decision date | Dec 29, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The ZipToe™ Hammertoe Fusion System is a permanent implant designed to fuse the proximal interphalangeal joint of the toes. It comprises a titanium alloy sleeve (ASTM F136) with two interior nitinol claws that deploy via surgical sutures ('ripcords') to fix the joint and minimize rotation.
The subject device is similar to the predicate in being an intramedullary design with interlocking geometry. Both are similar in sizing and materials. Minor differences in technological characteristics do not introduce different safety or effectiveness questions.
Mechanical testing per static 4-point bending, static pushout, static torsion, dynamic 4-point bending, fretting corrosion, pitting corrosion testing per ASTM F2129, and biocompatibility evaluation per ISO 10993-1.
The subject device is substantially equivalent to the Stryker Smart Toe II predicate (K201715) because it is identical in indications for use, similar in technological characteristics and design, and mechanical testing confirms equivalent performance and safety profile.
View the full FDA submission: accessdata.fda.gov