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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K253727.

When did Syndesmosis TightRope PRO receive FDA 510(k) clearance?

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

Who is the listed applicant for Syndesmosis TightRope PRO?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Syndesmosis TightRope PRO?

The FDA product code for Syndesmosis TightRope PRO is HTN.

Other records listing Arthrex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLCK242091Bolo Button SystemFusion Orthopedics

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.

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