Rotium Bioresorbable Wick

FDA 510(k) K183236 · Nanofiber Solutions, LLC

Substantially Equivalent

510(k) numberK183236

Submission

Device name
Rotium Bioresorbable Wick
Applicant
Nanofiber Solutions, LLC
Hilliard, OH, US
Received
November 20, 2018
Decision date
March 11, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

Other 510(k)s with product code MAI

510(k)DeviceApplicantDecision
K262357Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special Arthrex, Inc.08/07/2026SE
K253931Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional Arthrex, Inc.05/28/2026SE
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
K252946BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special Conmed Corporation10/15/2025SE
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

More from Stryker Endoscopy

510(k)DeviceDecision
K250021RotiumOWW · Traditional 02/27/2025SE
K241912BiochargeMAI · Special 07/29/2024SE
K231641Rotium Bioresorbable WickMAI · Special 07/05/2023SE
K201414Rotium Bioresorbable WickMAI · Special 06/25/2020SE
K173544Phoenix Wound MatrixQSZ · Traditional 03/02/2018SE

Questions and answers

When was Rotium Bioresorbable Wick cleared by the FDA?

Rotium Bioresorbable Wick (K183236) received a 510(k) decision of Substantially Equivalent on March 11, 2019, 111 days after the submission was received.

What is the product code of K183236?

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