This device just got cleared by the FDA. What your planning team needs before it shows up on the equipment list.
Device: ArthroTAK Tendon Anchor Kit
Decision Date: 2026-05-01
Applicant: ArthroTAK, LLC
Medical Specialty: Orthopedic
Pathway: 510(k)
About: An orthopedic tendon fixation device for arthroscopic or open procedures with no knot tying or suture management.
Facility Planning Implications
- ArthroTAK supports arthroscopic and open room workflow.
- The kit cuts suture management steps during setup.
- Optional dense-bone punch expands instrument tray planning.
- Cannula-optional use gives surgeons flexible access preferences.
FAQ
What is ArthroTAK Tendon Anchor Kit?
ArthroTAK Tendon Anchor Kit is an orthopedic tendon anchor used for tendon attachment or fixation in bone. The system deploys an anchor that expands within bone for immediate fixation.
What clinical setting is ArthroTAK Tendon Anchor Kit used in?
It is used in orthopedic procedure settings that perform arthroscopic or open soft tissue fixation. The website specifically describes arthroscopic high groove, arthroscopic suprapectoral, and open subpectoral approaches.
What room or space requirements does ArthroTAK Tendon Anchor Kit need?
This tendon anchor is used within existing orthopedic procedure workflows rather than requiring dedicated infrastructure. Facilities should plan standard sterile storage and case cart space for the kit and optional punch.
What systems does ArthroTAK Tendon Anchor Kit need to integrate with?
This tendon anchor does not show named digital or hardware integrations in the manufacturer content. Planning is mainly about tray configuration, surgeon preference support, and workflow compatibility.
Sources & image credit: FDA 510(k) Database · ArthroTAK
AI summary based on official and manufacturer data.