Cleared Traditional

IlluminOss Bone Stabilization System (K200295) - FDA 510(k) Clearance

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

K200295 · Illuminoss Medical, Inc. · Orthopedic device
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Jun 2020
Decision
141d
Days
Class 2
Risk

K200295 is an FDA 510(k) clearance for the IlluminOss 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 June 25, 2020 after a review of 141 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

Submission Details

510(k) Number K200295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2020
Decision Date June 25, 2020
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

MRCA, LLC
Robert Rabiner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

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