Definition: Intended To Be Used To Assist In The Implantation Of A Specific Knee Arthroplasty Device Or A Set Of Specific Knee Arthroplasty Devices. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, Selecting, Sizing, Attaching, Positioning Or
| Device Type ID | 4663 |
| Device Name | Knee Arthroplasty Implantation System |
| Physical State | A Device Accessory Or Set Of Device Accessories; |
| Technical Method | Aids The Surgeon In Performing The Implantation Of The Knee Implant |
| 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 | OOG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4663 |
| Device | Knee Arthroplasty Implantation System |
| Product Code | OOG |
| 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 | |
|---|---|
Loose Or Intermittent Connection | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Component Missing | 1 |
Device Dislodged Or Dislocated | 1 |
Failure To Adhere Or Bond | 1 |
Unstable | 1 |
Malposition Of Device | 1 |
Insufficient Information | 1 |
Material Deformation | 1 |
| Total Device Problems | 11 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConforMIS, Inc. | II | Oct-21-2015 |