| Device Type ID | 4529 |
| Device Name | Condylar Plate Fixation Implant |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| 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 | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JDP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4529 |
| Device | Condylar Plate Fixation Implant |
| Product Code | JDP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| CFR Regulation Number | 888.3030 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEPUY SYNTHES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 118 |
Adverse Event Without Identified Device Or Use Problem | 115 |
Unintended Movement | 28 |
Migration Or Expulsion Of Device | 11 |
Bent | 7 |
Device-Device Incompatibility | 6 |
Detachment Of Device Or Device Component | 6 |
Insufficient Information | 3 |
Fitting Problem | 2 |
Material Deformation | 2 |
Device Operates Differently Than Expected | 2 |
Corroded | 2 |
Screw | 2 |
Device Dislodged Or Dislocated | 2 |
Appropriate Term/Code Not Available | 2 |
Material Integrity Problem | 1 |
Migration | 1 |
Failure To Adhere Or Bond | 1 |
Material Twisted / Bent | 1 |
Operating System Becomes Nonfunctional | 1 |
Fracture | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Loosening Of Implant Not Related To Bone-Ingrowth | 1 |
Crack | 1 |
Mechanical Problem | 1 |
Difficult To Position | 1 |
| Total Device Problems | 319 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes, Inc. | II | Mar-04-2014 |