Not Cleared Direct

DEN160062 - IlluminOss Bone Stabilization System (FDA 510(k) Clearance)

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

DEN160062 · Illminoss Medical, Inc. · Orthopedic device
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Dec 2017
Decision
356d
Days
Class 2
Risk

DEN160062 is an FDA 510(k) submission (not cleared) 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 Illminoss Medical, Inc. (East Providence, US). The FDA issued a Not Cleared (DENG) decision on December 19, 2017 after a review of 356 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 356 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Illminoss Medical, Inc. devices

Submission Details

510(k) Number DEN160062 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 28, 2016
Decision Date December 19, 2017
Days to Decision 356 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 122d · This submission: 356d
Pathway characteristics

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.