# K253940: M.U.S.T. Pedicle Screw System - Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 28, 2026 after 140 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: 20 generations back to K040583 (2004). 337 ancestors in all.
No later device cites it as a predicate yet.
1 of 338 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234048: M.U.S.T. Pedicle Screw System - Extension, Medacta International S.A. (2024) Summary page 5.
- K141044: M.U.S.T. Extension, Medacta International (2014) Summary page 5.
- K162061: M.U.S.T. Pedicle Screw System, Medacta International S.A. (2016) Summary page 5.
- K193365: M.U.S.T. Pedicle Screw System, Medacta International S.A. (2020) Summary page 5.

## 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/K253940
Methodology: https://510kreport.com/methodology