| Device Type ID | 4566 |
| Device Name | Prosthesis, Toe, Constrained, Polymer |
| Regulation Description | Toe Joint Polymer Constrained Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| 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) |
| CFR Regulation Number | 888.3720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KWH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4566 |
| Device | Prosthesis, Toe, Constrained, Polymer |
| Product Code | KWH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Toe Joint Polymer Constrained Prosthesis. |
| CFR Regulation Number | 888.3720 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IN2BONES USA, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Device Disinfection Or Sterilization Issue | 3 |
Insufficient Information | 2 |
Device Expiration Issue | 1 |
Shelf Life Exceeded | 1 |
Malposition Of Device | 1 |
Loss Of Osseointegration | 1 |
Component Or Accessory Incompatibility | 1 |
Device Dislodged Or Dislocated | 1 |
Device Reprocessing Problem | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
| Total Device Problems | 22 |