| K-number | K250596 |
| Device name | Arthrex FiberTak Suture Anchor |
| Applicant | Arthrex, Inc. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Mar 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Arthrex FiberTak Suture Anchor is an all-suture knotless anchor made of a hollow polyester braid sheath with braided polyester sutures (UHMWPE or polyblend with nylon), preloaded on a disposable inserter. It is used to fix soft tissue to bone in orthopedic surgical procedures across the shoulder, elbow, hip, knee, foot/ankle, and hand/wrist.
The subject device is a line extension of predicate K221396 with identical basic design, indications for use, packaging, shelf-life, biocompatibility, manufacturing, and sterilization processes. The only modification is to the pre-loaded sutures, which the submitter considers minor.
Cyclic pull-out testing was conducted to demonstrate performance equivalence to the predicate. Bacterial endotoxin testing per EP 2.6.14/USP <85> was performed to verify pyrogen limit specifications.
The subject device shares identical design features, indications for use, intended use, and manufacturing processes as the predicate K221396. Performance testing shows statistical equivalence in cyclic pull-out strength. The only difference—modification to pre-loaded sutures—is characterized as minor and does not raise new safety or effectiveness concerns. Thus, substantial equivalence is supported by the unchanged fundamental design and comparable performance data.
View the full FDA submission: accessdata.fda.gov