| Device |
filler, bone void, calcium compound containing single approved aminoglycoside |
| Definition |
A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection. |
| Physical State |
Putty or paste implanted by injection or by hand |
| Technical Method |
The resorbable calcium salt bone void filler fills bony defects to allow for new bone formation while the aminoglycoside reduces recurrence of chronic osteomyelitis of long bones. |
| Target Area |
Bones of the extremities |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QRR |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3046
|
|---|
| 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 |
