# K162061: M.U.S.T. Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Oct 21, 2016 after 87 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). 148 ancestors in all.
15 later devices descend from it; 4 cite it directly.
1 of 164 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.
- K141988: M.U.S.T Pedicle Screw System, Medacta International (2014) Summary page 4.
- K141044: M.U.S.T. Extension, Medacta International (2014) Summary page 4.
- K132878: M.U.S.T. Extension, Medacta International (2013) Summary page 4.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 4.
- K984578: Synergy D2 Spinal Implants, Interpore Cross Intl. (1999) Summary page 5.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 5.

## Most influential descendants
- K171369: M.U.S.T. MINI Posterior Cervical Screws System (2017), 8 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
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own
- K241034: Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (2024), 2 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/K162061
Methodology: https://510kreport.com/methodology