← Back to catalogue

Duralastic Anatomical Malar Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K973574

by Hanson Medical, Inc.

Identifiers

510(k) Number
K973574 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 Duralastic Anatomical Malar Implant is a crescent-shaped, concave-convex silicone elastomer implant designed for facial augmentation or reconstruction. Classified as an implant under FDA product code LZK, it provides permanent structural support to the cheek contours or maxillary zygoma, filling the inframalar sulcus and augmenting the mid-cheek area. Manufactured in mirror-image pairs, these implants are intended for use in general plastic surgery procedures.

This device is inserted via intraoral or ciliary incisions by surgeons and is supplied as a sterile, single-use implant. It is regulated under FDA 510(k) clearance (K973574) and falls under Class II medical devices. The implants are available in multiple registration numbers (e.g., 1032347, 3003897287) and are intended for permanent placement in the infraorbital area to enhance facial symmetry. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

What is the Duralastic Anatomical Malar Implant used for?

The Duralastic Anatomical Malar Implant is designed for facial augmentation or reconstruction, specifically to provide permanent structural support to the cheek contours or maxillary zygoma. It fills the inframalar sulcus and enhances the mid-cheek area, improving facial symmetry in plastic surgery procedures. Its crescent-shaped, concave-convex design allows for natural contouring.

How is the Duralastic Malar Implant supplied and what are its sterility and usage guidelines?

The implant is supplied as a sterile, single-use device, adhering to strict sterile medical device protocols. It is intended for permanent placement in the infraorbital area and must be handled and stored according to sterile medical device guidelines to maintain integrity and safety. The manufacturer ensures sterility before packaging, so no additional sterilization is required by the clinician.

Are the Duralastic Malar Implants reusable or single-use?

The Duralastic Anatomical Malar Implants are explicitly designed for single-use only. This ensures patient safety by preventing cross-contamination and maintaining sterility. Reuse is not recommended or supported by the manufacturer.

What registration numbers or models are available for the Duralastic Malar Implant?

The Duralastic Anatomical Malar Implant is available in multiple registration numbers, including 1032347, 3003897287, 1825527, 3001890623, and others. These variants are manufactured in mirror-image pairs to accommodate bilateral placement. The specific registration number should be confirmed with the manufacturer or distributor to ensure the correct size and model are selected for the procedure.

How should the Duralastic Malar Implant be stored?

The implant must be stored in accordance with sterile medical device protocols to preserve its integrity and sterility. This includes maintaining the original packaging until immediate use, storing in a clean, dry environment protected from contamination, and avoiding exposure to extreme temperatures or direct sunlight. Follow the manufacturer’s instructions for storage duration and conditions.

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: DURALASTIC ANATOMICAL MALAR IMPLANT (K973574) — FDA 510 (k) | Innolitics, Malar Implants - Hanson Medical Inc. - Medical & Health Care Product ..., K973574 FDA 510 (k) - DURALASTIC ANATOMICAL MALAR IMPLANT

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hanson Medical, Inc.

Sources (1)

  • FDA 510(k) K973574 24 fields · synced Oct 6, 2026