| Device Type ID | 4470 |
| Device Name | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Regulation Description | Ankle Joint Metal/polymer Semi-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 | 510(k) |
| CFR Regulation Number | 888.3110 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HSN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4470 |
| Device | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Product Code | HSN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ankle Joint Metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3110 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ASCENSION ORTHOPEDICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DT MEDTECH LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TORNIER INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WRIGHT MEDICAL TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 121 |
Insufficient Information | 94 |
Migration Or Expulsion Of Device | 34 |
Migration | 15 |
Break | 12 |
Loss Of Osseointegration | 12 |
Device Operates Differently Than Expected | 11 |
Disassembly | 11 |
Appropriate Term/Code Not Available | 11 |
Failure To Adhere Or Bond | 8 |
Naturally Worn | 8 |
Device Inoperable | 7 |
Mechanical Problem | 6 |
Noise, Audible | 5 |
Malposition Of Device | 5 |
Fracture | 5 |
Use Of Device Problem | 5 |
Difficult To Position | 3 |
Collapse | 3 |
Mechanical Jam | 3 |
Loosening Of Implant Not Related To Bone-Ingrowth | 3 |
Knob | 2 |
Positioning Problem | 2 |
Metal Shedding Debris | 2 |
Missing Information | 2 |
Unstable | 1 |
Material Integrity Problem | 1 |
Material Twisted / Bent | 1 |
Bent | 1 |
Material Disintegration | 1 |
Component Missing | 1 |
Device Dislodged Or Dislocated | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Loss Of Or Failure To Bond | 1 |
Device Difficult To Setup Or Prepare | 1 |
Mechanics Altered | 1 |
Material Erosion | 1 |
Loose Or Intermittent Connection | 1 |
Detachment Of Device Or Device Component | 1 |
Missing Value Reason | 1 |
Guide | 1 |
Component Incompatible | 1 |
Locking Mechanism | 1 |
| Total Device Problems | 409 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Exactech, Inc. | II | Dec-06-2017 |
| 2 | Integra LifeSciences Corp. | II | Feb-11-2017 |
| 3 | Integra LifeSciences Corp. | II | Jun-29-2016 |
| 4 | Tornier, Inc | II | Aug-26-2015 |