Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040) → NDK — System, External Fixator (With Metallic Invasive Components)

# NDK · System, External Fixator (With Metallic Invasive Components)

_Orthopedic · 21 CFR 888.3040 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDK

## Overview

- **Product Code:** NDK
- **Device Name:** System, External Fixator (With Metallic Invasive Components)
- **Regulation:** [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K140649](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDK/K140649.md) | VECTRIX EXTERNAL FIXATOR | 3D Medical Concepts, LLC | Dec 29, 2014 | SESE |
| [K122208](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDK/K122208.md) | EXTERNAL FIXATOR SYSTEM | Christopher D. Endara | Dec 20, 2012 | SESE |
| [K101375](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDK/K101375.md) | TRIMED X-FIX | TriMed, Inc. | Sep 15, 2010 | SESE |

## Top Applicants

- 3D Medical Concepts, LLC — 1 clearance
- Christopher D. Endara — 1 clearance
- TriMed, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDK](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDK)

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