Companies / Promethean Restorative

Medical device company profile

Promethean Restorative

Developer of the DYNAMIS implant and instrumentation system for sacroiliac joint fusion.

Manufacturer / DeveloperOrthopedics & MusculoskeletalSpineCommercial-stage

Headquarters🇺🇸Castle Rock, Colorado, United States

FoundedNot confirmed

Commercial statusCommercially availableDYNAMIS is offered to clinicians through the company.

EmployeesNot confirmed

Estimated revenueNot confirmed

Official websiteprometheanrestorative.com ↗

Company overview

Promethean Restorative develops spinal implant technology with a current focus on sacroiliac joint stabilization and fusion. Its DYNAMIS Implant System pairs a 3D-printed titanium implant with procedure-specific instrumentation.

The implant incorporates threaded fixation, an internal lattice and a porous surface. The company provides product resources, surgical materials and instructions for use to support surgeons evaluating the system.

^{[1][2][3][4][5][6]}

Products & regulatory status How does MedTechIndex get this information?

Summary

FDA cleared the DYNAMIS SI Screw System under K243565 on February 28, 2025 and the DYNAMIS Implant System under K251075 on April 25, 2025. The separate DYNAMIS Navigation System received clearance K252962 on January 12, 2026; that navigation decision is not counted as an additional implant clearance. ^[8][9][10]

Regulatory snapshot How to read this snapshot

U.S. FDA

2
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-30.

Commercial portfolio snapshot

Documented commercial product families.

Sacroiliac joint fusion system

DYNAMIS Implant System ↗

3D-printed titanium implant and instrumentation for stabilizing and fusing the sacroiliac joint. ^[7]

FDA 510(k)-cleared implant / screw system

Contact Promethean for system availability.

10 Cited Sources

Accessed 10/30/2026

Last substantive review: 10/30/2026

[1] FDA 510(k) database — research search ↗U.S. Food and Drug Administration · regulatory databaseFDA database search page; not an individual device record.

[2] FDA enforcement reports database — research search ↗U.S. Food and Drug Administration · regulatory databaseFDA database search page; not an individual device record.

[3] FDA PMA database — research search ↗U.S. Food and Drug Administration · regulatory databaseFDA database search page; not an individual device record.

[4] FDA medical-device recall database — research search ↗U.S. Food and Drug Administration · regulatory databaseFDA database search page; not an individual device record.

[5] Company and DYNAMIS system ↗Promethean Restorative · company website

[6] Company contact ↗Promethean Restorative · company website

[7] DYNAMIS Implant System ↗Promethean Restorative · company website

[8] FDA 510(k) decision K243565 ↗U.S. Food and Drug Administration · regulatory database

[9] FDA 510(k) decision K251075 ↗U.S. Food and Drug Administration · regulatory database

[10] FDA 510(k) decision K252962 ↗U.S. Food and Drug Administration · regulatory database