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Rotium Bioresorbable Wick

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201414

by Nanofiber Solutions Llc

Identifiers

510(k) Number
K201414 FDA 510(k)
FDA Product Code
MAI 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 Rotium Bioresorbable Wick is a biodegradable, soft tissue fastener and fixation device. It is designed to be placed at the tendon-bone interface to support the healing cascade and improve long-term outcomes after rotator cuff repair. The device is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.

The Rotium Bioresorbable Wick is supplied as a single-use, bioresorbable device. It is classified as a Class II device with product code MAI and is regulated under the FDA 510(k) clearance, with the reference number K201414. The device is manufactured by Nanofiber Solutions, LLC and has a regulation number of 888.3030.

Frequently asked questions

What is the Rotium Bioresorbable Wick used for?

The Rotium Bioresorbable Wick is used to support the healing cascade and improve long-term outcomes after rotator cuff repair, specifically at the tendon-bone interface.

Is the Rotium Bioresorbable Wick a single-use device?

Yes, the Rotium Bioresorbable Wick is supplied as a single-use, bioresorbable device.

What regulatory classification does the Rotium Bioresorbable Wick have?

The Rotium Bioresorbable Wick is classified as a Class II device with product code MAI and is regulated under the FDA 510(k) clearance.

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: Rotium® Bioresorbable Wick - Atreon Orthopedics, Rotium Bioresorbable Wick by Nanofiber Solutions, LLC | FDA 510 (k) Summary, K201414 FDA 510 (k) - Rotium Bioresorbable Wick, Rotium Bioresorbable Wick (K201414) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nanofiber Solutions Llc
FDA Applicant
Nanofiber Solutions, LLC

Sources (1)

  • FDA 510(k) K201414 24 fields · synced Sep 23, 2026