Lag Screw
by Onyx Medical Corp. 510(k)
Active
510(k) K903244
Overview
The Lag Screw is a type of orthopedic fixation device classified under the product code HWC, designed for internal fixation of fractures, osteotomies, arthrodeses, and nonunions in the small bones and joints of the foot and ankle. It provides stable fixation by compressing bone fragments together, facilitating proper alignment and healing. This device is intended for use in both intra-articular and extra-articular applications, ensuring secure fixation in complex fracture patterns.
The Lag Screw is supplied as a reusable surgical instrument and is regulated under FDA 510(k) clearance (K903244) with a decision of Substantially Equivalent (SESE) within the Orthopedic advisory committee. It is not specified as single-use or sterile upon packaging in the available data. The device is intended for use in controlled surgical settings and adheres to standard orthopedic fixation protocols. No additional regulatory approvals beyond the 510(k) clearance are mentioned.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903244 | Date30 Jul 1990 | 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- Withdrawn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
- SESE Substantially Equivalent
Other devices from Onyx Medical LLC
Questions
What is the Lag Screw used for in orthopedic surgery?
The Lag Screw is designed for internal fixation of fractures, osteotomies, arthrodeses, and nonunions in the small bones and joints of the foot and ankle. It works by compressing bone fragments together, ensuring proper alignment and promoting healing. This device is suitable for both intra-articular (within a joint) and extra-articular (outside a joint) applications, making it versatile for complex fracture patterns.
Is the Lag Screw single-use or reusable?
The Lag Screw is supplied as a reusable surgical instrument. Unlike single-use devices, it is intended for repeated use in controlled surgical settings, adhering to standard orthopedic fixation protocols. Reusability helps reduce waste and costs while maintaining sterility through proper cleaning and sterilization procedures.
What regulatory approval does the Lag Screw hold?
The Lag Screw holds FDA 510(k) clearance under the reference number K903244. This clearance was determined to be Substantially Equivalent (SESE) by the Orthopedic Advisory Committee, meaning it meets the performance criteria of a legally marketed predicate device. No additional regulatory approvals beyond this clearance are mentioned in the available data.
How is the Lag Screw supplied, and what sterility status does it have?
The available data does not specify whether the Lag Screw is supplied sterile or non-sterile. As a reusable device, it is intended for use in controlled surgical environments where sterility can be maintained through proper cleaning and sterilization processes before each use. Clinicians should follow established protocols to ensure the device remains sterile and safe for repeated surgical applications.
What product code category does the Lag Screw fall under?
The Lag Screw is classified under the FDA product code HWC, which categorizes it as an orthopedic fixation device. This classification aligns with its intended use for stabilizing fractures, osteotomies, and other bone-related procedures in the foot and ankle region.