| Device Type ID | 4554 |
| Device Name | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Regulation Description | Knee Joint Patellofemoral Polymer/metal 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 | 888.3540 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KRR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4554 |
| Device | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Product Code | KRR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Knee Joint Patellofemoral Polymer/metal Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARTHROCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARTHROSURFACE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 14 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Migration Or Expulsion Of Device | 4 |
Break | 4 |
Loose Or Intermittent Connection | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Appropriate Term/Code Not Available | 3 |
Device Dislodged Or Dislocated | 2 |
Device Operates Differently Than Expected | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Malposition Of Device | 2 |
Component Falling | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Noise, Audible | 1 |
Material Deformation | 1 |
Unintended Movement | 1 |
Detachment Of Device Component | 1 |
Loss Of Osseointegration | 1 |
Material Fragmentation | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Fracture | 1 |
Failure To Adhere Or Bond | 1 |
Material Integrity Problem | 1 |
Osseointegration Problem | 1 |
Metal Shedding Debris | 1 |
| Total Device Problems | 70 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | II | Apr-04-2016 |
| 2 | Zimmer Biomet, Inc. | II | Mar-14-2018 |
| 3 | Zimmer Biomet, Inc. | II | Feb-22-2016 |
| 4 | Zimmer, Inc. | II | Aug-26-2014 |