Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3010](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3010) → NDD — Cerclage, Fixation, Metallic

# NDD · Cerclage, Fixation, Metallic

_Orthopedic · 21 CFR 888.3010 · Class 2_

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

## Overview

- **Product Code:** NDD
- **Device Name:** Cerclage, Fixation, Metallic
- **Regulation:** [21 CFR 888.3010](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3010)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K003618](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDD/K003618.md) | WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 | Whiteside Biomechanics, Inc. | May 23, 2001 | SESE |

## Top Applicants

- Whiteside Biomechanics, Inc. — 1 clearance

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

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