# K243565: DYNAMIS™ SI Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Promethean Restorative, LLC
- Decided: Feb 28, 2025 after 102 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: 23 generations back to K930834 (1993). 221 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241574: iFuse TORQ® Implant System, SI-BONE, Inc. (2024) Summary page 5.
- K210402: Curiteva Sacroiliac Joint Fusion System, Curiteva, Inc. (2021) Summary page 5.
- K191748: Genesys Spine Sacroiliac Joint Fusion System, Genesys Spine (2019) Summary page 5.

## Most influential descendants
- K251075: DYNAMIS™ Implant System (2025), 0 descendants of its own

## Indications for use
The DYNAMIS T M SI Screw 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 T M SI Screw System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

Source page: https://510kreport.com/device/K243565
Methodology: https://510kreport.com/methodology