Definition: Call For PMAs To Be Filed By 12/26/96 Per 61 FR 50711 On 9/27/96
| Device Type ID | 4576 |
| Device Name | Prosthesis, Shoulder, Constrained, Metal/metal Or Metal/polymer Cemented |
| Regulation Description | Shoulder Joint Metal/metal Or Metal/polymer Constrained Cemented 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 | PMA |
| CFR Regulation Number | 888.3640 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KWR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4576 |
| Device | Prosthesis, Shoulder, Constrained, Metal/metal Or Metal/polymer Cemented |
| Product Code | KWR |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Shoulder Joint Metal/metal Or Metal/polymer Constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3640 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 17 |
Device Dislodged Or Dislocated | 6 |
Failure To Adhere Or Bond | 3 |
Appropriate Term/Code Not Available | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Migration Or Expulsion Of Device | 1 |
Detachment Of Device Or Device Component | 1 |
Loose Or Intermittent Connection | 1 |
Malposition Of Device | 1 |
| Total Device Problems | 33 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | The Anspach Effort, Inc. | II | Jun-25-2014 |