| K-number | K254306 |
| Device name | Aevumed FENIX Suture Anchor |
| Applicant | Aevumed, Inc. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Mar 4, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Aevumed FENIX Suture Anchor is a suture anchor made from HS Fiber UHMWPE/PET material, preloaded on a disposable inserter, designed for fixation of soft tissue to bone. It is available in 2.6mm and 1.8mm diameters, sterile, and for single use only. The device is intended for suture or tissue fixation across multiple anatomical sites including the shoulder, foot, ankle, knee, hand, wrist, elbow, and hip.
The FENIX Suture Anchors share the same intended use, geometric design, material, operational principle, sterilization method, packaging, and shelf life as the predicate RAPID Anchor (K223878). The minor differences between the FENIX and RAPID do not raise new questions of safety and effectiveness.
Not stated in this summary. The document references mechanical testing under static and dynamic tensile conditions for maximum displacement and pullout strength, but does not cite specific consensus standards (ISO, IEC, ASTM).
Substantial equivalence is based on non-clinical mechanical testing data showing the FENIX Suture Anchor demonstrated substantially equivalent pullout strength compared to the predicate FiberTak Suture Anchor (K181769). The sterilization, packaging, pyrogenicity/endotoxin monitoring, and biocompatibility are identical to the predicate RAPID device (K223878), and the minor design differences do not raise safety or efficacy concerns.
View the full FDA submission: accessdata.fda.gov