Abanza Tecnomed S.L · Class II · Cleared Feb 25, 2025
| K-number | K250238 |
| Device name | WasherCap Fixation System |
| Applicant | Abanza Tecnomed S.L |
| Product code | MBI |
| Device class | Class II |
| Decision date | Feb 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The WasherCap™ Fixation System is an implantable soft tissue fixation device consisting of a washer and cap made from PEEK polymer and a titanium alloy screw. It is intended to fixate soft tissue grafts, including tendons and ligaments, to bone during surgical procedures such as ACL reconstruction of the knee.
The proposed 11mm device is identical to its predicate except for a 1mm size difference, which extends compatibility with the full range of tendon grafts (6–11mm) used in ACL reconstruction. Materials, manufacturing processes, sterilization, and accessories are identical to the predicate device.
ASTM 2026 (PEEK biomaterial), ISO 5832-3 and ASTM F136 (titanium alloy). Mechanical testing verification used the same acceptance criteria and protocols as the predicate submission K212197.
The device has identical intended use, indications for use, operating principle, fundamental technology, and materials as the predicate K212197. The only change is a 1mm size increase to accommodate larger tendon grafts. Bench testing confirmed performance identical to the predicate using the same validated methodology. Since materials and manufacturing are unchanged, predicate biocompatibility data support the subject device. The size change does not introduce new safety or effectiveness questions, making the device substantially equivalent.
View the full FDA submission: accessdata.fda.gov