Cleared Traditional

Rotium

K250021 · Nanofiber Solutions, LLC · Orthopedic

Feb 2025

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K250021 is an FDA 510(k) clearance for the Rotium, a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWW), submitted by Nanofiber Solutions, LLC (Dublin, US). The FDA issued a Cleared decision on February 27, 2025, 55 days after receiving the submission on January 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K250021 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 2025
Decision Date	February 27, 2025
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWW — Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.