| Device |
filler, bone void, recombinant platelet-derived growth factor |
| Definition |
For use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions. |
| Physical State |
The product consists of 1.5, 3, 6, or 9 cc of beta-tricalcium phosphate in granule form and 1.5, 3, 6, or 9 ml of rhPDGF-BB (0.3 mg/ml) in liquid form. The two components are mixed in equal volumes prior to use. |
| Technical Method |
The platelet-derived growth factor component is intended to function as a chemo-attractant and mitogen for cells that stimulate the repair and growth of new bone. The osteoconductive calcium phosphate component is intended to act as a scaffold for new bone growth. |
| Target Area |
The product is utilized in the hindfoot and ankle for fusion procedures that include tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions. |
| Review Panel |
Orthopedic |
|---|
| Product Code | OYR |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
|
Not Classified Reason
|
For Export Only
|
|---|
| Submission Type |
Contact ODE
|
|---|
| Device Class |
Not Classified
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
