| Device Type ID | 4716 |
| Device Name | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| 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 | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LZJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4716 |
| Device | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Product Code | LZJ |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARTHROCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARTHROSURFACE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Loose Or Intermittent Connection | 2 |
Dull, Blunt | 1 |
Break | 1 |
Mechanical Problem | 1 |
Patient Device Interaction Problem | 1 |
Patient-Device Incompatibility | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arthrosurface, Inc. | II | Dec-23-2015 |