Cleared Traditional

IlluminOss Bone Stabilization System (K181228) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence.

K181228 · Illuminoss Medical, Inc. · Orthopedic device
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Aug 2018
Decision
115d
Days
Class 2
Risk

K181228 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 August 31, 2018 after a review of 115 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 K181228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2018
Decision Date August 31, 2018
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Musculoskeletal Clinical Regulatory Affairs
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.

Clinical Evidence

ClinicalTrials.gov
NCT02394080 Unknown Interventional Industry-sponsored

Safety and Efficacy Study of the Treatment of Humerus Fractures

CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures

44
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Acute Humerus Fractures
Study design Single group
Eligibility All sexes · 50 Years+
Sponsor IlluminOss Medical, Inc. (industry)
Started 2015-02-01 → Primary completion 2017-05-01 → Completed 2018-01-01
Primary outcome
Normal radiographic fracture healing
Secondary outcome
Assessment of the incidence of adverse events
View full study on ClinicalTrials.gov

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 K181228.
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