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# FDA Clears First Ray Bone Fixation Device
- URL: https://www.fdaweb.com/fda-clears-first-ray-bone-fixation-device/
- Published: 2016-05-16T12:00:00.000Z
- Updated: 2026-09-14T21:03:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135684

FDA has cleared a First Ray 510(k) for its CortiClamp System for small bone fixation. The device uses a second screw head that is attached to the distal end of the screw, providing screw heads on both ends of the screw shaft that create a bi-cortical clamping force, the company says. It includes an “all-in-one” instrument that serves as a reduction clamp, drill guide, countersink guide, depth gage and implant delivery guide, it says.

“The superior bi-cortical clamping force of the CortiClamp System has been proven in biomechanical testing,” First Ray says. The device offers “statistically significantly higher pull-out strength, providing approximately twice the strength in an osteoporotic bone model when compared to headless compression screws and cortical screws,” it says.