| Device |
rod, fixation, intramedullary and accessories, in-vivo cured, light-activated |
| Regulation Description |
In vivo cured intramedullary fixation rod. |
| 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. |
| Physical State |
Device includes a balloon component to contain the light sensitive liquid monomer. A light source (e.g., optic fiber) is used to polymerize and solidify the monomer into a hardened rigid structure. Once sufficiently cured, the device possesses adequate strength to withstand expected physiologic loads when used as indicated. |
| Technical Method |
A polymeric balloon is inserted into the intramedullary 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 to stabilize the fracture. |
| Target Area |
Device is intended to be used in long bones of the body. |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QAD |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3023
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
