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Meniscus Chin Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K944164

by Spectrum Designs, Inc.

Identifiers

510(k) Number
K944164 FDA 510(k)
FDA Product Code
LZK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3550 FDA 510(k)
Regulation Number
878.3550 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Meniscus Chin Implant is a silicone rubber solid device classified as an Implant, Malar under FDA nomenclature. It is designed for subcutaneous implantation to augment or reconstruct the chin, providing structural support and contour enhancement in plastic surgery procedures. The device is intended for use in patients requiring chin augmentation or correction of congenital or acquired deformities. Its meniscus-shaped profile allows for natural-looking results while maintaining stability within the soft tissues.

This device is supplied as a single-use, sterile implant and is regulated under FDA product code LZK as a Class II medical device. It was cleared via the Traditional 510(k) pathway in 1994 (K944164) and falls under FDA regulation 878.3550 for malar implants. Storage and handling must comply with sterile implant protocols, and its use is restricted to qualified surgeons in clinical settings. No additional regulatory approvals beyond the stated 510(k) clearance are implied.

Frequently asked questions

What is the Meniscus Chin Implant used for?

The Meniscus Chin Implant is designed for subcutaneous implantation to augment or reconstruct the chin. It provides structural support and contour enhancement in plastic surgery procedures, addressing congenital or acquired deformities. Its meniscus-shaped profile ensures natural-looking results while maintaining stability within soft tissues.

How is the Meniscus Chin Implant supplied and what are its sterility requirements?

The Meniscus Chin Implant is supplied as a single-use, sterile device. Sterility is critical for subcutaneous implantation, so it must be handled and stored according to sterile implant protocols to prevent contamination before use.

Is the Meniscus Chin Implant reusable or intended for single-use?

The Meniscus Chin Implant is explicitly intended for single-use only. Reuse is not recommended or approved, as it could compromise sterility and patient safety, particularly for an implanted device.

What regulatory pathway and approval does the Meniscus Chin Implant follow?

The Meniscus Chin Implant was cleared via the Traditional 510(k) pathway in 1994 under FDA product code LZK, classified as a Class II medical device. It falls under FDA regulation 878.3550 for malar implants and is restricted to use by qualified surgeons in clinical settings.

What storage and handling guidelines apply to the Meniscus Chin Implant?

The Meniscus Chin Implant must be stored and handled in compliance with sterile implant protocols to maintain its integrity and sterility. Improper storage could compromise the device’s safety and effectiveness before surgical use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K944164 FDA 510 (k) - MENISCUS CHIN IMPLANT, PDF K944164 MENISCUS CHIN IMPLANT - 510kdatabase.net, Device Listing 1474665669 - FDA.report, fda.innolitics.com, Spectrum Designs… — 18 FDA 510 (k)s · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spectrum Designs, Inc.

Sources (1)

  • FDA 510(k) K944164 24 fields · synced Oct 1, 2026