Prosthesis, Ankle, Uncemented, Non-Constrained
The Uncemented Non-Constrained Ankle Prosthesis is a surgically implanted total ankle replacement device intended to replace a diseased or damaged ankle joint. It features a tibial component made of cobalt-chromium-molybdenum alloy and a talar component of ultra-high molecular weight polyethylene, with minimal constraint allowing near-normal translation. As an FDA Class 3 device requiring Premarket Approval (PMA), it is subject to the most stringent regulatory pathway. The product code is NTG, reviewed by the Orthopedic panel, and it is flagged as both an implant and a life-sustaining support device.
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Basic Information
- Product Code
- NTG
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.