# NTG · Prosthesis, Ankle, Uncemented, Non-Constrained

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/NTG

## Overview

- **Product Code:** NTG
- **Device Name:** Prosthesis, Ankle, Uncemented, Non-Constrained
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P160036](/device/P160036.md) | Hintermann Series H3 Total Ankle Replacement System | Dt Medtech, LLC | Jun 4, 2019 | APPR |
| [P050050](/device/P050050.md) | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) | Djo Global | May 27, 2009 | APPR |

## Top Applicants

- Djo Global — 1 clearance
- Dt Medtech, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/NTG](https://fda.innolitics.com/productcode/NTG)

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