Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3940](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3940) → LZD — Joint, Temporomandibular, Implant

# LZD · Joint, Temporomandibular, Implant

_Dental · 21 CFR 872.3940 · Class 3_

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

## Overview

- **Product Code:** LZD
- **Device Name:** Joint, Temporomandibular, Implant
- **Regulation:** [21 CFR 872.3940](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3940)
- **Device Class:** 3
- **Review Panel:** [Dental](/submissions/DE)
- **Implant:** yes

## Identification

A total temporomandibular joint prosthesis is a device that is intended to be implanted in the human jaw to replace the mandibular condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.

## Classification Rationale

Class III.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P020016](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LZD/P020016.md) | WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | Sep 21, 2005 | APPR |
| [P000023](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LZD/P000023.md) | TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES | Nexus CMF, LLC | Jan 5, 2001 | APPR |
| [P980052](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LZD/P980052.md) | TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS | TMJ Concepts | Jul 2, 1999 | APPR |

## Top Applicants

- Biomet Microfixation, Inc. — 1 clearance
- Nexus CMF, LLC — 1 clearance
- TMJ Concepts — 1 clearance

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

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