Rotium Bioresorbable Wick

FDA 510(k) K231641 · Nanofiber Solutions, LLC

Substantially Equivalent

510(k) numberK231641

Submission

Device name
Rotium Bioresorbable Wick
Applicant
Nanofiber Solutions, LLC
Dublin, OH, US
Received
June 5, 2023
Decision date
July 5, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAI – Fastener, Fixation, Biodegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K260294SF Push-in AnchorMAI · Traditional Surgical Fusion Technologies GmbH03/27/2026SE
K254055OSSIOfiber® Suture AnchorMAI · Traditional OSSIO , Ltd.02/24/2026SE
K251680Biosteon® ScrewMAI · Traditional Biocomposites, Ltd.02/17/2026SE
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K252022OSSIOfiber® Interference ScrewMAI · Traditional OSSIO , Ltd.08/19/2025SE
K251309OSSIOfiber® Suture AnchorMAI · Special OSSIO , Ltd.05/27/2025SE
K250544Knotilus+ Biocomposite Knotless AnchorMAI · Traditional Stryker Endoscopy05/23/2025SE
K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorMAI · Traditional Stryker Endoscopy05/21/2025SE

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K201414Rotium Bioresorbable WickMAI · Special 06/25/2020SE
K183236Rotium Bioresorbable WickMAI · Traditional 03/11/2019SE
K173544Phoenix Wound MatrixQSZ · Traditional 03/02/2018SE

Questions and answers

When was Rotium Bioresorbable Wick cleared by the FDA?

Rotium Bioresorbable Wick (K231641) received a 510(k) decision of Substantially Equivalent on July 5, 2023, 30 days after the submission was received.

What is the product code of K231641?

The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.