| K-number | K253618 |
| Device name | QuadLock Fixation System |
| Applicant | Abanza Tecnomed S.L |
| Product code | MBI |
| Device class | Class II |
| Decision date | Jan 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The QuadLock™ Fixation System is a soft tissue-to-bone fixation device used during knee surgery to secure non-absorbable sutures or tapes (at least USP #2 or 1.4mm diameter) in ACL/PCL repair and ACL reconstruction procedures. It consists of a PEEK cap and titanium alloy screw that work together to hold soft tissue in place within a bone tunnel in skeletally mature pediatric and adult patients.
The QuadLock differs from its predicate (WasherCap™ Mini, K243712) primarily in size: it is larger than the predicate but smaller than the reference device (WasherCap™, K212197). Both devices share identical design (cap and screw components preloaded onto an insertion tool, not preloaded with sutures), materials, manufacturing process, packaging, and sterilization method (ethylene oxide). The subject device has narrower indications limited to knee ACL/PCL procedures, while the predicate covers additional shoulder and hand/wrist indications.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov