# K153664: M.U.S.T. Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Medacta International
- Decided: Jan 19, 2016 after 29 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: 15 generations back to K040583 (2004). 145 ancestors in all.
24 later devices descend from it; 5 cite it directly.
1 of 170 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 5.
- K141988: M.U.S.T Pedicle Screw System, Medacta International (2014) Summary page 5.

## Most influential descendants
- K171170: M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws (2017), 23 descendants of its own
- K171369: M.U.S.T. MINI Posterior Cervical Screws System (2017), 8 descendants of its own
- K193365: M.U.S.T. Pedicle Screw System (2020), 7 descendants of its own
- K200130: M.U.S.T. MINI Posterior Cervical Screws System (2020), 6 descendants of its own
- K203482: M.U.S.T. Pedicle Screw Extension and Long Tab Implants (2021), 5 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) 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.¢., fracture or dislocation); spinal stenosis; curvatures (i.¢., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K153664
Methodology: https://510kreport.com/methodology