Definition: The Device Is A Percutaneous Prosthetic Device For The Direct Skeletal Attachment Of A Prosthetic Limb.
| Device Type ID | 4754 |
| Device Name | Transfemoral Percutaneous Prosthetic |
| Physical State | The Device May Be Threaded, Or Coated To Provide Fixation To The Bone. The Device Is Made From Medical Grade Mettalic 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PJY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4754 |
| Device | Transfemoral Percutaneous Prosthetic |
| Product Code | PJY |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Device Slipped | 2 |
Detachment Of Device Or Device Component | 2 |
Patient Device Interaction Problem | 1 |
Osseointegration Problem | 1 |
| Total Device Problems | 10 |