Definition: For Use In Arthroplasty Of The Proximal Interphalangeal (PIP) Joint When The Patient: A) Has Soft Tissue And Bone That Can Provide Adequate Stabilization And Fixation Under High-demand Loading Conditions After Reconstruction; And B) Needs A Revision
| Device Type ID | 4746 |
| Device Name | High Demand, Revision, Semi-constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis |
| Physical State | Pyrolytic Carbon Implant |
| Technical Method | Implant |
| Target Area | Finger Joints |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | OMX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4746 |
| Device | High Demand, Revision, Semi-constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis |
| Product Code | OMX |
| Device Problems | |
|---|---|
Break | 2 |
Material Integrity Problem | 2 |
Fracture | 2 |
Detachment Of Device Component | 1 |
Out-Of-Box Failure | 1 |
| Total Device Problems | 8 |