NTG
- Product code
- NTG
- Device name
- Prosthesis, Ankle, Uncemented, Non-Constrained
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
- Flag
- Implant
- Flag
- Life-sustaining / life-supporting
FDA classification 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.
Official FDA classification page: NTG
Classification and pathway per current FDA publications. Data from openFDA (CC0).