Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Syndesmosis TightRope PRO

K-Number: K253727 · 2025-12-22

ApplicantArthrex, Inc.
Decision Date2025-12-22
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Syndesmosis TightRope PRO is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-12-22 under approval number K253727. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Syndesmosis TightRope PRO?

Syndesmosis TightRope PRO is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Arthrex, Inc.. The 510(k) number is K253727.

When was Syndesmosis TightRope PRO approved by the FDA?

Syndesmosis TightRope PRO received FDA 510(k) clearance on 2025-12-22, under approval number K253727.

What company makes Syndesmosis TightRope PRO?

Syndesmosis TightRope PRO is manufactured by Arthrex, Inc..

What is the FDA product code for Syndesmosis TightRope PRO?

The FDA product code for Syndesmosis TightRope PRO is HTN.

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

View all 168 devices →

Related Devices (Code: HTN)

K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc. K170440KISSloc Suture SystemArthrosurface, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑