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Cannulated Hemi Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190543

by Vilex In Tennessee, Inc.

Identifiers

510(k) Number
K190543 FDA 510(k)
FDA Product Code
KWD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3730 FDA 510(k)
Regulation Number
888.3730 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cannulated Hemi Implant is a prosthetic device classified as a Prosthesis, Toe, Hemi-, Phalangeal, designed to replace portions of the proximal phalanx or metatarsal head. It features cannulated (hollow) construction to facilitate bone engagement and fixation, providing structural support for toe joint arthroplasty.

This device is intended for single-use and is supplied sterile, requiring use with bone cement for secure implantation. It is regulated under FDA 510(k) clearance (K190543) and falls under product code KWD, classified as a Class II medical device. Storage and handling must adhere to sterile processing protocols to maintain integrity before use.

Frequently asked questions

What is the Cannulated Hemi Implant designed to replace?

The Cannulated Hemi Implant is specifically designed to replace portions of the proximal phalanx or metatarsal head in toe joint arthroplasty. Its cannulated (hollow) construction allows for improved bone engagement and fixation, providing structural support where natural bone has been compromised or removed.

How is the Cannulated Hemi Implant supplied and prepared for use?

The Cannulated Hemi Implant is supplied sterile and intended for single-use only. Before use, it must be handled according to sterile processing protocols to maintain its integrity. The device requires the use of bone cement during implantation to ensure secure fixation within the bone.

Is the Cannulated Hemi Implant reusable or designed for one-time use?

The Cannulated Hemi Implant is explicitly designed for single-use only. This ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical for orthopedic implants where infection risk must be minimized.

What regulatory pathway does the Cannulated Hemi Implant follow?

The Cannulated Hemi Implant follows the FDA 510(k) clearance pathway, classified as a Class II medical device under product code KWD. It was determined to be substantially equivalent to a legally marketed predicate device, as evidenced by the clearance number K190543. This classification reflects its role as a prosthetic device for toe joint replacement.

How should the Cannulated Hemi Implant be stored before use?

The Cannulated Hemi Implant must be stored according to sterile processing protocols to preserve its integrity. Proper storage conditions—such as sealed packaging, controlled humidity, and protection from contamination—are essential to ensure the device remains sterile and functional until use. Always follow manufacturer guidelines for storage duration and environmental requirements.

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: PDF Vilex, Inc. • 111 Moffitt Street • McMinnville, TN 37110 USA Phone: 800 ..., Cannulated Hemi Implant (K190543) - FDA 510 (k), Cannulated Hemi Implant (K190543) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vilex In Tennessee, Inc.

Sources (1)

  • FDA 510(k) K190543 24 fields · synced Oct 5, 2026