Cleared Traditional

Rotium Bioresorbable Wick (K183236) - FDA 510(k) Clearance

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

K183236 · Nanofiber Solutions, LLC · Orthopedic device
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Mar 2019
Decision
111d
Days
Class 2
Risk

K183236 is an FDA 510(k) clearance for the Rotium Bioresorbable Wick. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Nanofiber Solutions, LLC (Hilliard, US). The FDA issued a Cleared decision on March 11, 2019 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nanofiber Solutions, LLC devices

Submission Details

510(k) Number K183236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2018
Decision Date March 11, 2019
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 122
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