510(k) K253727

Syndesmosis TightRope PRO by Arthrex, Inc. — Product Code HTN

K253727 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Syndesmosis TightRope PRO". The FDA issued a decision of Substantially Equivalent on December 22, 2025. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has at least 10 other 510(k) clearances on record.