Promethean Restorative, LLC - FDA 510(k) Cleared Devices

Promethean Restorative, LLC is dedicated to addressing pain and suffering associated with spinal conditions. The company provides innovative solutions for stabilizing and fusing the sacroiliac joint. With a manufacturing facility in Castle Rock, Colorado, Promethean Restorative develops advanced orthopedic implants and instrumentation for spine surgery.

The company has received 3 FDA 510(k) clearances from 3 total submissions, with all submissions focused on orthopedic devices. First clearance in 2025 and latest clearance in 2026 demonstrate active regulatory engagement. The company remains actively engaged in bringing new spine stabilization technologies to market.

Promethean Restorative's product portfolio includes the DYNAMIS™ Implant System, featuring state-of-the-art 3D printed titanium implants with advanced instrumentation. The system incorporates proprietary technologies including a patent-pending thread design for true compression of the ilium and sacrum, titanium lattice structures for bone integration, and self-drilling insertion capabilities. These devices represent the company's core focus on sacroiliac joint fusion solutions.

Explore the company's FDA 510(k) clearance history, device names, product codes, and clearance dates in the regulatory database.