| Device |
prosthesis, ankle, uncemented, non-constrained |
| Definition |
An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint.The device limits minimally (less than normal anatomic constraints) translation in one or more planes.It has no linkage across-the-joint.This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene. |
| Review Panel |
Orthopedic |
|---|
| Product Code | NTG |
|---|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
