Chrysalis Intelligence · Product Codes · QAD

QAD · Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Orthopedic · 4 clearances · 1 unique sponsors

Device class
Class II
Regulation 888.3023
Total clearances
4
2020-06-25 → 2024-01-19
Last 12 months
0
Unique sponsors
1
Definition

What is Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

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.
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3023
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Illuminoss Medical, Inc. 4 0 2024-01-19
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
20690 CPT High CPT for application of intramedullary fixation rod/nail with treatment of fracture
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-01-19 K233436 Illuminoss Medical, Inc. IlluminOss Photodynamic Bone Stabilization System
2020-10-27 K202887 Illuminoss Medical, Inc. IlluminOss Bone Stabilization System
2020-08-13 K201961 Illuminoss Medical, Inc. IlluminOss Photodynamic Bone Stabilization System
2020-06-25 K200295 Illuminoss Medical, Inc. IlluminOss Bone Stabilization System