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Dorsal Columella Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K944166

by Spectrum Designs, Inc.

Identifiers

510(k) Number
K944166 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 Dorsal Columella Implant is a silicone elastomer device designed for nasal augmentation in rhinoplasty procedures. It is classified as a malar implant and is intended to enhance the nasal dorsum and columella region, providing structural support and aesthetic enhancement. Constructed from a soft, flexible material, it is tailored for use in reconstructive and cosmetic nasal surgery.

This implant is supplied as a single-use, sterile device and is regulated under FDA 510(k) clearance (K944166) as a Class II medical device under product code LZK. It is intended for use in operating room settings by qualified surgeons in general and plastic surgery. Storage and handling must comply with sterile medical device protocols to ensure integrity before implantation.

Frequently asked questions

What is the Dorsal Columella Implant used for?

The Dorsal Columella Implant is designed specifically for nasal augmentation during rhinoplasty procedures. It enhances the nasal dorsum and columella region by providing structural support and improving aesthetics. This makes it ideal for both reconstructive and cosmetic nasal surgeries where patients seek refinement of the nasal bridge and columella.

How is the Dorsal Columella Implant supplied and what are its sterility and usage guidelines?

The implant is supplied as a single-use, sterile device, ensuring safety and compliance with medical standards. It must be handled and stored according to sterile medical device protocols to maintain its integrity before implantation. This includes proper packaging, storage in a clean environment, and adherence to manufacturer guidelines to prevent contamination.

Is the Dorsal Columella Implant reusable, or is it intended for one-time use?

The Dorsal Columella Implant is explicitly designed for single-use only. This classification aligns with FDA guidelines for medical implants to ensure patient safety and reduce the risk of infection or material degradation from repeated use. After implantation, the device should not be reused.

What material is the Dorsal Columella Implant made from, and why is this important?

The implant is constructed from a silicone elastomer, a soft and flexible material chosen for its biocompatibility and durability. Silicone is well-suited for nasal augmentation because it mimics natural tissue properties, reduces the risk of adverse reactions, and provides long-term stability without compromising the surrounding nasal structure.

Who can use the Dorsal Columella Implant, and where is it intended for application?

The implant is intended for use by qualified surgeons in operating room settings, specifically within the fields of general and plastic surgery. Its design and regulatory clearance (FDA 510(k)) ensure it is suitable for controlled surgical environments where precision and sterility are critical. Only trained professionals should handle and implant this device.

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: K944166 FDA 510 (k) - DORSAL COLUMELLA IMPLANT, DORSAL COLUMELLA IMPLANT (K944166) — FDA 510 (k) | Innolitics, Nasal dorsal implant - Columella Style 9 - Spectrum Designs Medical ..., Class 2 Device Recall Spectrum Designs MedicalNasal Dorsal Columella ..., DEVICE: Dorsal Columella Implant (Firm) (M724DCI03F1)

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) K944166 24 fields · synced Oct 1, 2026