# K251075: DYNAMIS™ Implant System

- Pathway: 510(k) (Special)
- Applicant: Promethean Restorative, LLC
- Decided: Apr 25, 2025 after 17 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K930834 (1993). 222 ancestors in all.
No later device cites it as a predicate yet.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243565: DYNAMIS™ SI Screw System, Promethean Restorative, LLC (2025) Summary page 5.

## Indications for use
The DYNAMIS ™ Implant System is indicated for sacroiliac joint fusion for: • Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. • Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The DYNAMIS ™ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

Source page: https://510kreport.com/device/K251075
Methodology: https://510kreport.com/methodology