Definition: Indicated For: 1. Painful And Disabled Knee Joint Resulting From Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis Where One Or More Compartments Are Involved. 2. Correction Of Varus, Valgus, Or Posttraumatic Deformity. 3. Correction Or Revis
| Device Type ID | 4660 |
| Device Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
| Physical State | May Include: Femoral Component Tibial Component Metal Backed Patellar Component Tibial Insert Patella Insert All Poly Patellar Component Instrumentation |
| Technical Method | This Device Is Intended To Be Implanted To Replace A Knee Joint. The Device Limits Translation And Rotation In One Or More Planes Via The Geometry Of Its Articulating Surfaces. It Has No Linkage Across The Joint. This Generic Type Of Device Includes |
| Target Area | Knee |
| 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 Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OIY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4660 |
| Device | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
| Product Code | OIY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Knee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3560 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 158 |
Failure To Adhere Or Bond | 102 |
Unstable | 34 |
Appropriate Term/Code Not Available | 32 |
Fracture | 23 |
Migration Or Expulsion Of Device | 23 |
Adverse Event Without Identified Device Or Use Problem | 21 |
Difficult To Insert | 12 |
Device Operates Differently Than Expected | 8 |
Migration | 4 |
Malposition Of Device | 4 |
Noise, Audible | 4 |
Defective Device | 3 |
Naturally Worn | 3 |
Nonstandard Device | 3 |
Fitting Problem | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Device Packaging Compromised | 3 |
Osseointegration Problem | 3 |
Loss Of Or Failure To Bond | 3 |
Component Missing | 3 |
Device Dislodged Or Dislocated | 2 |
Disassembly | 2 |
Residue After Decontamination | 2 |
Suture | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Loose Or Intermittent Connection | 2 |
Scratched Material | 1 |
Difficult To Position | 1 |
Break | 1 |
Crack | 1 |
Packaging Problem | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Deformation | 1 |
Plate | 1 |
Pitted | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Difficult Or Delayed Positioning | 1 |
| Total Device Problems | 475 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Encore Medical, Lp | II | Oct-26-2015 |
| 2 | Zimmer, Inc. | II | Feb-04-2015 |