Cleared Traditional

K233436 - IlluminOss Photodynamic Bone Stabilizat...

K233436 is an FDA 510(k) clearance for IlluminOss Photodynamic Bone Stabilizat..., manufactured by Illuminoss Medical, Inc.. The device is a Class 2 Orthopedic device with product code QAD cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K233436 · Illuminoss Medical, Inc. · Orthopedic device
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Jan 2024
Decision
98d
Days
Class 2
Risk

K233436 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 January 19, 2024 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3023 - 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 Illuminoss Medical, Inc. devices

FDA 510(k) Submission Details - K233436

510(k) Number K233436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2023
Decision Date January 19, 2024
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QAD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - QAD Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated

Devices cleared under the same product code (QAD) and FDA review panel - the closest regulatory comparables to K233436.
IlluminOss Bone Stabilization System
K202887 · Illuminoss Medical, Inc. · Oct 2020
IlluminOss Photodynamic Bone Stabilization System
K201961 · Illuminoss Medical, Inc. · Aug 2020
IlluminOss Bone Stabilization System
K200295 · Illuminoss Medical, Inc. · Jun 2020
IlluminOss Photodynamic Bone Stabilization System
K183145 · Illuminoss Medical, Inc. · Dec 2018
IlluminOss Bone Stabilization System
K181228 · Illuminoss Medical, Inc. · Aug 2018