# K193083: M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Dec 3, 2019 after 28 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: 7 generations back to K903810 (1990). 13 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171595: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, Medacta International S.A. (2017) Summary page 4.

## Most influential descendants
- K203247: iFuse-TORQ™ Implant System (2021), 17 descendants of its own
- K213667: iFuse-TORQ® Implant System (2022), 15 descendants of its own
- K222605: iFuse TORQ® Implant System (2022), 14 descendants of its own
- K231689: iFuse TORQ® Implant System (2023), 5 descendants of its own
- K241574: iFuse TORQ® Implant System (2024), 4 descendants of its own

## Indications for use
The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is intended for use in skeletally mature patients for fracture fixation of small and long bones of the pelvis, and for sacroiliac joint fusion for patients suffering from sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K193083
Methodology: https://510kreport.com/methodology