Product code NTG

Device name

Prosthesis, Ankle, Uncemented, Non-Constrained

Medical specialty

Unknown

Device class

3

Review panel

OR

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset