Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3550](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3550) → LZK — Implant, Malar

# LZK · Implant, Malar

_General, Plastic Surgery · 21 CFR 878.3550 · Class 2_

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

## Overview

- **Product Code:** LZK
- **Device Name:** Implant, Malar
- **Regulation:** [21 CFR 878.3550](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3550)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

## Classification Rationale

Class II.

## Recent Cleared Devices (20 of 40)

Showing 20 most recent of 40 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K021419](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K021419.md) | AART MALAR IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | Jul 2, 2002 | SESE |
| [K002886](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K002886.md) | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | Implantech Associates, Inc. | Nov 24, 2000 | SESE |
| [K992240](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K992240.md) | PILLAR MALAR IMPLANT | Pillar Surgical, Inc. | Nov 22, 1999 | SESE |
| [K983756](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K983756.md) | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | Nov 20, 1998 | SESE |
| [K982763](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K982763.md) | SEARE BIOMEDICAL MALAR IMPLANTS | Seare Biomedical Corp. | Sep 30, 1998 | SESE |
| [K981835](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K981835.md) | SILIMED MALAR IMPLANT | Silimed, LLC | Jul 9, 1998 | SESE |
| [K980141](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K980141.md) | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | Spectrum Designs, Inc. | Mar 3, 1998 | SESE |
| [K980140](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K980140.md) | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | Spectrum Designs, Inc. | Mar 3, 1998 | SESE |
| [K980139](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K980139.md) | SPECTRUM DESIGNS PROFILE MALAR IMPLANT | Spectrum Designs, Inc. | Mar 3, 1998 | SESE |
| [K973502](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K973502.md) | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | Implantech Associates, Inc. | Nov 7, 1997 | SESE |
| [K973574](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K973574.md) | DURALASTIC ANATOMICAL MALAR IMPLANT | Hanson Medical, Inc. | Oct 24, 1997 | SESE |
| [K971479](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K971479.md) | DURALASTIC ANATOMICAL MALAR IMPLANTS | Allied Biomedical Corp. | Jul 18, 1997 | SESE |
| [K970400](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K970400.md) | BONE SOURCE HYDROXYAPATITE | Orthofix, Inc. | May 2, 1997 | SESE |
| [K964443](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K964443.md) | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | Dec 20, 1996 | SESE |
| [K962261](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K962261.md) | IMPLANTECH WM NASAL-LABIAL IMPLANT | Implantech Associates, Inc. | Aug 19, 1996 | SESE |
| [K961511](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K961511.md) | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | Jun 28, 1996 | SESE |
| [K961210](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K961210.md) | SAM FACIAL IMPLANT | W. L. Gore & Associates, Inc. | Jun 19, 1996 | SESE |
| [K961080](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K961080.md) | MEDIAL MALAR IMPLANT | Rand Scientific Corp. | Apr 19, 1996 | SESE |
| [K960362](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K960362.md) | PERMAMESH HYDROXYLAPATITE MATRIX | Ceramed Corp. | Mar 20, 1996 | SESE |
| [K960354](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZK/K960354.md) | PERMAMESH-D HYDROXYLAPATITE MATRIX | Ceramed Corp. | Mar 20, 1996 | SESE |

## Top Applicants

- Implantech Associates, Inc. — 11 clearances
- Spectrum Designs, Inc. — 6 clearances
- Byron Medical — 3 clearances
- Surgical Technology Laboratories, Inc. — 2 clearances
- King & Spalding — 2 clearances

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

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