Cleared Traditional

K250021 - Rotium (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250021 · Nanofiber Solutions, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2025
Decision
55d
Days
Class 2
Risk

K250021 is an FDA 510(k) clearance for the Rotium. Classified as Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWW), Class II - Special Controls.

Submitted by Nanofiber Solutions, LLC (Dublin, US). The FDA issued a Cleared decision on February 27, 2025 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nanofiber Solutions, LLC devices

Submission Details

510(k) Number K250021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

All 9
Devices cleared under the same product code (OWW) and FDA review panel - the closest regulatory comparables to K250021.
VersaCoat Tendon Protector (VTP-44G2)
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BioBrace®
K242187 · Conmed Corporation · Nov 2024
BioBrace® Reinforced Implant
K241906 · Conmed Corporation · Jul 2024
VersaWrap
K240817 · Alafair Biosciences, Inc. · Jun 2024
SpinMedix Absorbable Fibrous Membrane
K222220 · Celestray Biotech Company, LLC., · Jul 2023
FlexBand
K230316 · International Life Sciences · May 2023