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Creed Cannulated Screws

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223847

by Glw, Inc.

Identifiers

510(k) Number
K223847 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Creed Cannulated Screws are orthopedic fixation devices classified as cannulated compression screws. These screws are designed for internal fixation of fractures, providing stable bone alignment through threaded engagement. Available in headed and headless configurations, they feature diameters of 2.5 mm, 4.3 mm, 5.6 mm, and 7.4 mm, with self-drilling and self-tapping options for precise placement. Their cannulated design allows for guidewire-assisted insertion, enhancing accuracy during surgical procedures.

These screws are supplied in sterile packaging for single-use applications in orthopedic surgery. The radiotranslucent material improves intraoperative visualization of bone and joint spaces, distinguishing them from traditional metal implants. They are intended for use in settings requiring precise fixation, such as fracture stabilization or joint reconstruction. The device holds FDA 510(k) clearance under the Orthopedic advisory committee, with a classification of Special and a product code of HWC.

Frequently asked questions

What are Creed Cannulated Screws used for?

Creed Cannulated Screws are designed for internal fixation of fractures, ensuring stable bone alignment through threaded engagement. Their cannulated design allows guidewire-assisted insertion, which enhances precision during surgical procedures like fracture stabilization or joint reconstruction. The radiotranslucent material also improves visibility of bone and joint spaces during surgery.

How are Creed Cannulated Screws supplied and intended for use?

These screws are supplied in sterile packaging exclusively for single-use applications in orthopedic surgery. The sterile packaging ensures safety and compliance with surgical standards, preventing cross-contamination and ensuring reliability in clinical settings.

What sizes and configurations are available for Creed Cannulated Screws?

Creed Cannulated Screws come in four diameters: 2.5 mm, 4.3 mm, 5.6 mm, and 7.4 mm. They are available in both headed and headless configurations, as well as self-drilling and self-tapping options. This variety allows surgeons to select the appropriate screw for specific anatomical and clinical requirements.

Are Creed Cannulated Screws reusable, or are they intended for single-use?

Creed Cannulated Screws are explicitly designed for single-use applications. The sterile packaging and orthopedic fixation purpose align with medical device standards that prioritize patient safety and infection control, making reuse unsuitable and unsafe.

Why is the radiotranslucent material an advantage in these screws?

The radiotranslucent material in Creed Cannulated Screws improves intraoperative visualization by allowing clearer imaging of bone and joint spaces during surgery. This feature distinguishes them from traditional metal implants and helps surgeons achieve more precise placement and alignment, reducing potential complications.

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: Creed™ Cannulated Compression Screws - GLW Medical, Creed New - GLW Medical, Creed™ Cannulated Compression Screws - Innov8ortho

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Glw, Inc.

Sources (1)

  • FDA 510(k) K223847 24 fields · synced Oct 1, 2026