| K-number | K252635 |
| Device name | ArthroTAK Tendon Anchor Kit |
| Applicant | ArthroTAK, LLC |
| Product code | MBI |
| Device class | Class II |
| Decision date | May 1, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The ArthroTAK Tendon Anchor Kit is a surgical device consisting of a PEEK anchor with a proximal tack and distal bullet component, along with a pre-loaded inserter and optional bone punch. It is intended for soft-tissue to bone fixation in biceps tenodesis shoulder procedures.
The device uses polyetheretherketone (PEEK) material identical to the primary predicate device (K260004). Its design features and dimensions are similar to the SnapShot Fixation System (K143037). The ArthroTAK implant comprises two interconnected components designed for insertion into bone.
ASTM F3690-24 (insertion and fatigue/pull-to-failure testing), ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3:2017 (sterilization validation), and ISO 10993-1:2018 (biological evaluation).
The ArthroTAK Tendon Anchor Kit is substantially equivalent because it shares identical implant material (PEEK) with the primary predicate, the same intended use (soft tissue fixation in biceps tenodesis), and similar design features and dimensions to the reference device. Nonclinical testing demonstrates the device is as safe, effective, and performs as well as the predicate devices.
View the full FDA submission: accessdata.fda.gov