Device |
osseoanchored prostheses for the rehabilitation of transfemoral amputees |
Definition |
The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb. |
Physical State |
The device may be threaded, or coated to provide fixation to the bone. The device is made from medical grade metallic components. |
Technical Method |
The device is implanted into the femur to allow a fixation point for standard prosthetic limbs. |
Target Area |
Femur of amputee patients. |
Review Panel |
Orthopedic |
Product Code | PJY |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |