← Back to catalogue

Curvilinear Chin Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K980463

by Spectrum Designs, Inc.

Identifiers

510(k) Number
K980463 FDA 510(k)
FDA Product Code
FWP 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)

This device is a Prosthesis, Chin, Internal (product code FWP), designed for facial augmentation or reconstruction of the mandibular or chin area. It is a silicone-based implant intended to reshape or enhance the contour of the chin through surgical placement beneath the skin and muscle.

The Curvilinear Chin Implant is supplied sterile and intended for single-use. It is classified as a Class II device under FDA regulations (878.3550) and was granted FDA 510(k) clearance in 1998. Available in multiple sizes (as referenced by registration numbers), it is intended for use in surgical settings by qualified plastic surgeons. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

What is the Spectrum Designs Curvilinear Chin Implant used for?

The Curvilinear Chin Implant is designed for facial augmentation or reconstruction of the mandibular or chin area. It reshapes or enhances the chin’s contour through surgical placement beneath the skin and muscle, providing a more defined or symmetrical appearance. It is intended for patients seeking structural improvement in the chin region, whether due to congenital differences, trauma, or cosmetic preferences.

How is the Curvilinear Chin Implant supplied and prepared for use?

The implant is supplied sterile and intended for single-use only. It must be handled using sterile medical device protocols to maintain its integrity and sterility before surgical implantation. The packaging ensures it remains uncontaminated until opened in a controlled surgical environment.

Is the Curvilinear Chin Implant reusable, or is it meant for one-time use?

The Curvilinear Chin Implant is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, structural integrity, or patient safety. Each implant is intended for one surgical procedure and should not be reused between patients.

What sizes or models are available for the Curvilinear Chin Implant?

The Curvilinear Chin Implant comes in multiple sizes, each identified by a unique registration number (e.g., 1032347, 1018470, etc.). These sizes allow surgeons to select the most appropriate implant for the patient’s anatomical requirements, ensuring proper contouring and symmetry. The manufacturer provides detailed sizing guides to assist in selection.

How should the Curvilinear Chin Implant be stored before use?

The implant must be stored in accordance with sterile medical device protocols to preserve its sterility and structural integrity. This includes keeping it in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures the implant remains safe and effective for its intended 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: SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT (K980463) — FDA 510(k ..., K980463 FDA 510(k) - SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT, Spectrum Designs, Inc. FDA 510 (k) Products (1994-1999), Spectrum Designs Curvilinear Chin Implant 510 (k) FDA Premarket ...

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
Spectrum Designs, Inc.

Sources (1)

  • FDA 510(k) K980463 24 fields · synced Oct 1, 2026