# K210427: M.U.S.T. Midline Cortical (MC) Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 20, 2021 after 68 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). 148 ancestors in all.
No later device cites it as a predicate yet.
1 of 149 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K171758: M.U.S.T. Combined Set Screws, Medacta International S.A. (2017) Summary page 4.
- K072022: Valeo Pedicle Screw Spinal System, Amedica Corp. (2007) Summary page 4.

## Indications for use
The M.U.S.T. Pedicle screws 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/K210427
Methodology: https://510kreport.com/methodology