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IlluminOss Bone Stabilization System

by Illminoss Medical, Inc.

De Novo DEN160062

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN160062 Date19 Dec 2017DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
QAD
Device Class
Class II
Regulation
21 CFR Part 888.3023
Advisory Committee
Orthopedic
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IlluminOss Bone Stabilization System is a photodynamic intramedullary fixation device that provides supplemental or primary stability for bone fractures. It is designed to be used in conjunction with other fracture fixation systems in anatomical sites such as the femur and tibia, and can provide primary stability in humeral fractures and impending fractures.

This system is minimally invasive and light-activated, with a surgical technique that is easy to perform. It does not present artifacts at postoperative imaging, potentially allowing for prompt radiotherapy and chemotherapy. The device is supplied as a Class II medical device with FDA 510(k) clearance under product code QAD.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the IlluminOss Bone Stabilization System used for?

    The IlluminOss Bone Stabilization System is a photodynamic intramedullary fixation device that provides supplemental or primary stability for bone fractures. It can be used with other fixation systems in femur and tibia fractures, and provides primary stability in humeral fractures and impending fractures.

  • How is the IlluminOss Bone Stabilization System supplied?

    The IlluminOss Bone Stabilization System is supplied as a Class II medical device with FDA 510(k) clearance under product code QAD. It is manufactured by Illminoss Medical, Inc. and is designed to be used in conjunction with other fracture fixation systems.

  • What are the advantages of the IlluminOss System over traditional fixation methods?

    The IlluminOss System is minimally invasive and light-activated with an easy-to-perform surgical technique. It does not present artifacts at postoperative imaging, potentially allowing for prompt radiotherapy and chemotherapy. This makes it particularly useful in cases where imaging clarity is important for subsequent treatments.

  • In which anatomical sites can the IlluminOss Bone Stabilization System be used?

    The IlluminOss System can be used in anatomical sites such as the femur and tibia, providing supplemental or primary stability. It can also provide primary stability in humeral fractures and impending fractures, making it versatile for various orthopedic applications.