# K193365: M.U.S.T. Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jan 27, 2020 after 54 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: 17 generations back to K040583 (2004). 147 ancestors in all.
7 later devices descend from it; 3 cite it directly.
1 of 155 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132878: M.U.S.T. Extension, Medacta International (2013) Summary page 4.
- K171170: M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws, Medacta International S.A. (2017) Summary page 4.
- K121115: M.U.S.T Pedicle Screw System, Medacta International (2012) Summary page 4.
- K153664: M.U.S.T. Pedicle Screw System, Medacta International (2016) Summary page 4.
- K141988: M.U.S.T Pedicle Screw System, Medacta International (2014) 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 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/K193365
Methodology: https://510kreport.com/methodology