Cleared Special

K201961 - IlluminOss Photodynamic Bone Stabilization System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201961 · Illuminoss Medical, Inc. · Orthopedic device
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Aug 2020
Decision
30d
Days
Class 2
Risk

K201961 is an FDA 510(k) clearance for the IlluminOss Photodynamic Bone Stabilization System. Classified as Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated (product code QAD), Class II - Special Controls.

Submitted by Illuminoss Medical, Inc. (East Providence, US). The FDA issued a Cleared decision on August 13, 2020 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3023 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Illuminoss Medical, Inc. devices

Submission Details

510(k) Number K201961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2020
Decision Date August 13, 2020
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QAD Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3023
Definition Is A Device Intended To Be Implanted That Consists Of A Polymeric Balloon That Is Inserted Into The Medullary (bone Marrow) Canal Of Long Bones For The Fixation Of Fractures. The Balloon Is Infused With A Liquid Monomer That Causes The Balloon To Fill The Medullary Canal Of The Fractured Bone. The Device Is Then Exposed To A Light Source That Polymerizes The Light-activated Monomer Within The Balloon Creating A Hardened Rigid Structure.
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.