| K-number | K260561 |
| Device name | Arthrex FiberTak Suture Anchor |
| Applicant | Arthrex, Inc. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Mar 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Arthrex FiberTak Suture Anchor is an all-suture soft-tissue fixation device made from ultra-high molecular weight polyethylene and/or polyester. It is designed to be impacted into a pilot hole and manually tensioned to fix sutures (soft tissue) to bone across multiple anatomical sites including the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip in various reconstructive and repair procedures. The device is sterile, single-use, and newly approved for osteochondral fixation and fractures with autograft and allograft tissues in the knee and hip.
The subject device is identical to the primary predicate (K221396) except for the addition of osteochondral fixation and fracture indications. It employs an all-suture push-in design with UHMWPE and/or polyester materials, impacted via an inserter with manual tensioning to set the anchor. The device operates on similar principles to the predicate Arthrex Bio-Compression Screw, with any differences considered minor and not raising new safety or effectiveness concerns.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov