CrossRoads Screw System
by Crossroads Extemity Systems, LLC 510(k)
Active
510(k) K191342
Overview
The CrossRoads Screw System is a smooth or threaded metallic bone fixation fastener (21 CFR 888.3040), classified under Product Code HWC. It is designed for orthopedic applications, including fracture repair, fixation, osteotomy, joint fusion, reconstruction, and arthrodesis of bones. The system employs metallic screws to stabilize bone structures, ensuring proper alignment and healing. Its threaded or smooth design accommodates various clinical needs, from simple fractures to complex reconstructions.
This device is supplied as a sterile, single-use orthopedic implant and is intended for use in surgical settings. It is regulated under FDA 510(k) clearance (K191342) as substantially equivalent to predicate devices, adhering to Class II regulatory standards. Storage and handling must comply with sterile medical device protocols. The system is not MRI-safe unless explicitly stated in accompanying documentation, and sizes are determined by manufacturer specifications for compatibility with targeted anatomical applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191342 | Date19 Aug 2019 | 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- Withdrawn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 Crossroads Extemity Systems, LLC
Questions
What clinical applications is the CrossRoads Screw System designed for?
The CrossRoads Screw System is engineered for orthopedic procedures including fracture repair, bone fixation, osteotomy, joint fusion (arthrodesis), and complex bone reconstruction. Its threaded or smooth screw designs provide versatility to address both simple fractures and intricate anatomical challenges, ensuring stable alignment during healing.
How is the CrossRoads Screw System supplied, and what are its sterility and reuse requirements?
The system is supplied as a sterile, single-use orthopedic implant. Sterility is maintained through manufacturer-controlled packaging, and it is intended exclusively for one-time surgical use to prevent contamination risks. Reuse is not recommended due to potential compromise of sterility and structural integrity.
Are the screws MRI-safe, and how should they be stored?
The CrossRoads Screw System is not inherently MRI-safe unless explicitly documented in accompanying materials. For storage, follow sterile medical device protocols: keep in sealed, sterile packaging until use, and store in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and functionality.
What distinguishes the threaded screws from the smooth screws in this system?
The threaded screws are designed for applications requiring deeper or more secure fixation, such as joint fusion or complex reconstructions, where grip and resistance to pull-out are critical. Smooth screws, conversely, are suited for scenarios where minimal tissue trauma or gliding is preferred, such as certain fracture repairs or less constrained environments.
How are screw sizes determined for specific anatomical applications?
Screw sizes are determined by manufacturer specifications tailored to anatomical compatibility. The system includes a range of diameters and lengths to match the targeted bone type and procedure, ensuring optimal stability without over-constraining or under-fitting the fixation site. Consult the provided sizing guides or surgical technique documentation for precise selection.