Syndesmosis TightRope PRO— 510(k) K253727

Name: FDA 510(k) clearance K253727
Creator: U.S. Food and Drug Administration
Published: 2025-12-22

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K253727 for Syndesmosis TightRope PRO, Substantially Equivalent on 2025-12-22. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-11-24
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTN

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K253115 — LARS ACJ2026-06-10
K252081 — SportLinc Syndesmosis Device2026-03-27
K251643 — Synchfix EVT2025-10-29
K251134 — RipCord2025-07-11
K243624 — Acu-Sinch Knotless Mini2025-01-23

More clearances from Arthrex, Inc.

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K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System2026-06-25
K253931 — Arthrex Bioabsorbable PushLock Suture Anchors2026-05-28

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.