Definition: The Device Is Intended To Replace The Medial Condyle And The Patellofemoral Compartment Of The Distal Femur With A Single Device. The Device Is Meant To Be Used With A Uni-compartmental Tibial Base And Insert And A Resurfacing Patella. The Device Is
| Device Type ID | 4646 |
| Device Name | Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Regulation Description | Knee Joint Patellofemorotibial Polymer/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 | 888.3560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NPJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4646 |
| Device | Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Product Code | NPJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Knee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MAKO SURGICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 131 |
Insufficient Information | 114 |
Fracture | 77 |
Material Integrity Problem | 24 |
Adverse Event Without Identified Device Or Use Problem | 23 |
Crack | 21 |
Material Deformation | 21 |
Loss Of Osseointegration | 19 |
Packaging Problem | 12 |
Scratched Material | 11 |
Malposition Of Device | 10 |
Mechanical Problem | 9 |
Positioning Problem | 8 |
Fitting Problem | 8 |
Naturally Worn | 7 |
Device Operates Differently Than Expected | 7 |
Degraded | 6 |
Appropriate Term/Code Not Available | 6 |
Difficult To Insert | 6 |
Device Damaged By Another Device | 5 |
Osseointegration Problem | 5 |
Unstable | 4 |
Device Difficult To Setup Or Prepare | 4 |
Device Dislodged Or Dislocated | 3 |
Device Packaging Compromised | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Device Contaminated During Manufacture Or Shipping | 3 |
Dent In Material | 2 |
Unintended Movement | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
No Apparent Adverse Event | 2 |
Use Of Device Problem | 2 |
Decoupling | 2 |
Migration Or Expulsion Of Device | 2 |
Bent | 2 |
Difficult To Remove | 1 |
Material Twisted / Bent | 1 |
Material Discolored | 1 |
Failure To Adhere Or Bond | 1 |
Corroded | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Deformation Due To Compressive Stress | 1 |
Tip | 1 |
Material Distortion | 1 |
Difficult To Position | 1 |
Device Expiration Issue | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Noise, Audible | 1 |
Installation-Related Problem | 1 |
Material Fragmentation | 1 |
Hole In Material | 1 |
Material Too Rigid Or Stiff | 1 |
| Total Device Problems | 583 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConforMIS, Inc. | II | Oct-21-2015 |
| 2 | Mako Surgical Corporation | II | Jun-01-2018 |
| 3 | Mako Surgical Corporation | II | Mar-01-2016 |
| 4 | Mako Surgical Corporation | II | Mar-04-2014 |