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Tensyn Band

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131850

by Dallen Medical, Inc.

Identifiers

510(k) Number
K131850 FDA 510(k)
FDA Product Code
HTN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tensyn Band is a synthetic ligament replacement device designed for acromioclavicular joint and coracoacromial ligament repair. Classified under product code HTN as an orthopedic device, it is intended to stabilize shoulder separations by providing mechanical support to injured or deficient ligaments in the shoulder girdle.

This device is supplied as a single-use, non-sterile implant intended for surgical application. It is regulated under FDA 510(k) clearance (K131850) through the Traditional pathway, with a clearance date of November 15, 2013. The Tensyn Band is manufactured by Dallen Medical, Inc., and is intended for use in orthopedic surgical procedures requiring ligamentous reinforcement.

Frequently asked questions

What is the Tensyn Band used for in shoulder surgery?

The Tensyn Band is a synthetic ligament replacement designed specifically for acromioclavicular joint and coracoacromial ligament repair. It offers mechanical stabilization to injured or deficient ligaments in the shoulder girdle, helping restore function and integrity during procedures for shoulder separations.

Is the Tensyn Band intended for single-use or repeated use?

The Tensyn Band is supplied as a single-use device. This ensures sterility and safety for each surgical procedure, as reuse could compromise integrity and introduce infection risks.

How is the Tensyn Band supplied, and is it sterile?

The Tensyn Band is supplied in a non-sterile state, intended for surgical preparation and sterilization by the facility prior to use. This allows hospitals to follow their own protocols for sterilization, ensuring compatibility with their operating room workflows.

What regulatory pathway does the Tensyn Band follow?

The Tensyn Band received FDA clearance through the Traditional 510(k) pathway, specifically under the Orthopedic advisory committee (OR). It was determined to be substantially equivalent to a legally marketed device, with clearance granted on November 15, 2013.

What product code classifies the Tensyn Band?

The Tensyn Band is classified under product code HTN, which categorizes it as an orthopedic device for ligamentous reinforcement in surgical applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FDA Clears Dallen Medical's Tensyn™ Band for AC/CC Joint Stabilization, K131850 FDA 510 (k) - TENSYN BAND | Dallen Medical, Inc., Dallen Medical, Inc. FDA 510 (k) Products (2013-2017), TENSYN BAND (K133858) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dallen Medical, Inc.

Sources (1)

  • FDA 510(k) K131850 24 fields · synced Oct 1, 2026