Cannulated Cancellous Screw
by Onyx Medical Corp. 510(k)
Active
510(k) K931680
Overview
The Cannulated Cancellous Screw is a surgical orthopedic fixation device designed for internal fixation of bone fractures. It features a hollow core (cannulated design) to facilitate insertion over a guidewire, providing stability in cancellous bone—porous, spongy bone typically found at the ends of long bones and in vertebrae. This screw type is intended for applications requiring secure fixation while minimizing disruption to bone integrity.
Supplied sterile and intended for single-use, the Cannulated Cancellous Screw is regulated under FDA 510(k) clearance (K931680) as a Class II device (Product Code: HWC). It is used in orthopedic settings, such as trauma or joint surgery, and must be stored according to manufacturer instructions to maintain sterility. No MRI safety information is specified, and sizes or additional variants are not detailed in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK931680 | Date4 May 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Other devices from Onyx Medical LLC
Questions
What is the Cannulated Cancellous Screw designed for?
The Cannulated Cancellous Screw is specifically engineered for internal fixation of bone fractures, particularly in cancellous bone—the spongy, porous tissue found at the ends of long bones and in vertebrae. Its hollow core allows it to be inserted over a guidewire, reducing disruption to bone integrity while providing stable fixation during orthopedic procedures like trauma or joint surgery.
How is the Cannulated Cancellous Screw supplied and intended for use?
This device is supplied sterile and is intended for single-use only. The sterility ensures safety during surgical procedures, and its single-use designation aligns with best practices for infection control in orthopedic settings. Always follow the manufacturer’s storage guidelines to preserve sterility before use.
Can the Cannulated Cancellous Screw be reused?
No, the Cannulated Cancellous Screw is explicitly designed for single-use only. Reusing medical devices, especially orthopedic fixation hardware, poses significant risks of infection, compromised structural integrity, and potential failure during surgery. Adhering to single-use protocols ensures patient safety and device performance.
Are there different sizes or variants of this screw?
The provided data does not specify available sizes or variants for the Cannulated Cancellous Screw. For precise selection, clinicians should consult the manufacturer’s catalog or technical documentation, which may detail dimensions or configurations compatible with specific surgical applications.
How should the Cannulated Cancellous Screw be stored to maintain sterility?
To maintain sterility, the Cannulated Cancellous Screw must be stored according to the manufacturer’s instructions, which likely include keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. Proper storage prevents contamination and ensures the device remains ready for sterile surgical use.