Definition: An Elbow Joint Metal/polymer Constrained Uncemented Prosthesis Is A Device Intended To Be Implanted To Replace An Elbow Joint.
| Device Type ID | 4753 |
| Device Name | Elbow Joint Metal/polymer, Constrained, Porous Coated, Uncemented Prosthesis |
| Physical State | The Components Have A Porous Coating Made Of Ti-6Al-4V Alloy Powder. The Coating Is Further Enhanced By A Layer Of Hydroxyapatite. |
| Technical Method | The Device Prevents Dislocation In More Than One Anatomic Plane And Consists Of Two Components That Are Linked Together. It Is Designed To Achieve Biological Fixation To Bone Without The Use Of Bone Cement. |
| Target Area | Elbow |
| 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 | Enforcement Discretion |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PIX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4753 |
| Device | Elbow Joint Metal/polymer, Constrained, Porous Coated, Uncemented Prosthesis |
| Product Code | PIX |