# K171758: M.U.S.T. Combined Set Screws

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Aug 1, 2017 after 48 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K040583 (2004). 143 ancestors in all.
7 later devices descend from it; 2 cite it directly.
1 of 151 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121115: M.U.S.T Pedicle Screw System, Medacta International (2012) Summary page 4.

## Most influential descendants
- K203482: M.U.S.T. Pedicle Screw Extension and Long Tab Implants (2021), 5 descendants of its own
- K241034: Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (2024), 2 descendants of its own
- K234048: M.U.S.T. Pedicle Screw System - Extension (2024), 1 descendant of its own
- K260286: Dynamo™ Spinal Cement; Salvo® Spine System (2026), 0 descendants of its own
- K253940: M.U.S.T. Pedicle Screw System - Extension (2026), 0 descendants of its own

## Indications for use
The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K171758
Methodology: https://510kreport.com/methodology