| Device Type ID | 4585 |
| Device Name | Prosthesis, Wrist, Hemi-, Ulnar |
| Regulation Description | Wrist Joint Ulnar (hemi-wrist) Polymer 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 Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KXE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4585 |
| Device | Prosthesis, Wrist, Hemi-, Ulnar |
| Product Code | KXE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Wrist Joint Ulnar (hemi-wrist) Polymer Prosthesis. |
| CFR Regulation Number | 888.3810 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APTIS MEDICAL, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 3 |
Fracture | 2 |
Migration Or Expulsion Of Device | 2 |
Device Operates Differently Than Expected | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Naturally Worn | 1 |
Packaging Problem | 1 |
Material Erosion | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Howmedica Osteonics Corp. | II | Aug-20-2015 |