Definition: An Ankle Joint Metal/polymer Non-constrained Uncemented Prosthesis Is A Device Intended To Be Implanted To Replace An Ankle Joint. The Device Limits Minimally (less Than Normal Anatomic Constraints) Translation In One Or More Planes. It Has No Linkag
| Device Type ID | 4740 |
| Device Name | Prosthesis, Ankle, Uncemented, Non-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 | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NTG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4740 |
| Device | Prosthesis, Ankle, Uncemented, Non-constrained |
| Product Code | NTG |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 67 |
Insufficient Information | 49 |
Fracture | 39 |
Break | 27 |
Appropriate Term/Code Not Available | 24 |
Inadequacy Of Device Shape And/or Size | 14 |
Unintended Movement | 12 |
Device Operates Differently Than Expected | 11 |
Improper Or Incorrect Procedure Or Method | 10 |
Unstable | 9 |
Naturally Worn | 9 |
Malposition Of Device | 8 |
Patient-Device Incompatibility | 7 |
Migration Or Expulsion Of Device | 5 |
Failure To Osseointegrate | 4 |
Degraded | 4 |
Device Slipped | 4 |
Entrapment Of Device | 3 |
Screw | 3 |
Bearings | 2 |
Use Of Device Problem | 2 |
Device Dislodged Or Dislocated | 2 |
Therapeutic Or Diagnostic Output Failure | 2 |
Driver | 2 |
Pin | 2 |
Material Erosion | 2 |
Failure To Align | 2 |
Material Deformation | 2 |
Detachment Of Device Component | 1 |
Spring | 1 |
Stretched | 1 |
Device Expiration Issue | 1 |
Flaked | 1 |
Loose Or Intermittent Connection | 1 |
Positioning Problem | 1 |
Material Integrity Problem | 1 |
Bent | 1 |
Device Reprocessing Problem | 1 |
Human-Device Interface Problem | 1 |
Tip | 1 |
Shaft | 1 |
| Total Device Problems | 340 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DT MedTech, LLC | II | Nov-07-2018 |