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Mini TightRope

by Arthrex, Inc. 2 variants

510(k) K133275

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133275 Date30 Jan 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HTN
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mini TightRope is a flexible fixation device classified under orthopedic fixation devices, designed for soft-tissue and ligamentous stabilization in foot, ankle, and hand procedures. It provides an alternative to rigid screw or screw-and-plate fixation by suspending bones without overconstraining joints, ensuring reproducible stabilization for pathologies such as hallux valgus, Lisfranc injuries, and thumb metacarpal instability.

This device is supplied as a sterile, single-use system and is intended for use in orthopedic surgical settings. It is approved under FDA 510(k) clearance (K133275) and falls under the Orthopedic (OR) advisory committee classification. The system includes components for foot, ankle, and hand applications, with specific reference codes like VAR-2801, and is regulated as a Traditional 510(k) submission.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of procedures is the Mini TightRope specifically designed to assist with in the foot, ankle, and hand?

    The Mini TightRope is designed for soft-tissue and ligamentous stabilization in foot, ankle, and hand procedures. It is particularly suited for pathologies like hallux valgus (bunion deformities), Lisfranc injuries (midfoot fractures), and thumb metacarpal instability, offering an alternative to rigid screw or screw-and-plate fixation by suspending bones without overconstraining joints.

  • Is the Mini TightRope system reusable or intended for single-use, and how is it supplied?

    The Mini TightRope is supplied as a sterile, single-use system only. It is intended for one-time use in orthopedic surgical settings to ensure patient safety and prevent cross-contamination. The system includes components tailored for foot, ankle, and hand applications, such as the reference code VAR-2801.

  • What regulatory pathway was followed for FDA clearance of the Mini TightRope, and what does that mean for its use?

    The Mini TightRope received FDA 510(k) clearance (K133275) under a Traditional 510(k) submission, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance falls under the Orthopedic (OR) advisory committee classification and confirms its compliance with U.S. regulatory standards for orthopedic fixation devices.

  • Are there different sizes or models available for the Mini TightRope, and how do I know which one to select?

    While the provided data does not list specific sizes or models numerically, the Mini TightRope system is designed with application-specific components for foot, ankle, and hand procedures. The VAR-2801 reference code suggests at least one variant exists, and selection should be based on the anatomical site and pathology being treated, as outlined in the device’s intended use for soft-tissue and ligamentous stabilization.