Metal Cannulated Screw
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221090 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 Metal Cannulated Screw is a cannulated orthopedic screw designed for internal fixation of bone fractures. It features a hollow core to accommodate guide wires or other instruments, enabling precise placement in complex anatomical sites. This device is classified under orthopedic hardware and is intended for use in surgical procedures requiring stable bone alignment and fixation.
This device is supplied sterile and intended for single-use. It is regulated under the FDA 510(k) clearance (K221090) and MDR, with sizes including 2.4 mm, 3.0 mm, 4.0 mm, and 7.5 mm cannulated screws. Storage requires adherence to manufacturer guidelines for sterile packaging integrity. No specific MRI safety classification is stated in the available data.
Frequently asked questions
What are the key differences between this cannulated screw and a solid-core orthopedic screw in terms of surgical use?
The Metal Cannulated Screw features a hollow core that allows surgeons to pass guide wires or other instruments through it, enabling precise placement in complex anatomical sites. This is particularly useful in surgeries where accuracy is critical, such as in long bone fractures or when navigating around obstacles like blood vessels. In contrast, solid-core screws lack this feature, which may limit their use in cases requiring guided insertion.
Are these screws reusable, or are they meant for single-use only?
These Metal Cannulated Screws are explicitly designed for single-use only, as stated in the manufacturer’s instructions. This ensures sterility and reduces the risk of cross-contamination or device degradation between procedures, which is critical in orthopedic surgeries where infection control is paramount.
What sizes are available for this cannulated screw, and how might I choose the right one for a patient?
The available sizes for this device are 2.4 mm, 3.0 mm, 4.0 mm, and 7.5 mm. The selection depends on factors like the patient’s bone density, fracture location, and the specific surgical requirements. For example, smaller diameters (2.4 mm or 3.0 mm) may be used in pediatric cases or for less dense bone, while larger diameters (4.0 mm or 7.5 mm) are typically chosen for adult long bones or high-stress fixation sites.
How should I store these screws to maintain their sterility and integrity?
The manufacturer specifies that these screws must be stored according to their sterile packaging guidelines to preserve sterility and prevent contamination. This typically involves keeping the packaging sealed, dry, and protected from physical damage or extreme temperatures until use. Always follow the storage instructions provided in the packaging to ensure the device remains safe for single-use.
What regulatory pathways does this device follow, and how does that affect its use in clinical practice?
This Metal Cannulated Screw is cleared under the FDA’s 510(k) pathway (K221090) and complies with the EU’s Medical Device Regulation (MDR). The 510(k) clearance indicates it is deemed substantially equivalent to a legally marketed device, meaning it meets FDA standards for safety and effectiveness. Clinically, this means it can be used with confidence in procedures requiring internal bone fixation, as it has undergone the necessary regulatory scrutiny.
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: K221090 FDA 510(k) - Metal Cannulated Screw, Home - Double Medical, Cannulated Screw Fixation,Headless Compression Screw,Cannulated Screw ..., Metal Cannulated Screw — FDA 510 (k) K221090 | MedTracker, Metal Cannulated Screw | Medical Device Navigator
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221090 | Class II | Active |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- FDA Applicant
- Double Medical Technology, Inc.
Sources (2)
- FDA 510(k) K221090 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026