# K203482: M.U.S.T. Pedicle Screw Extension and Long Tab Implants

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jan 26, 2021 after 60 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: 18 generations back to K040583 (2004). 153 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 159 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153664: M.U.S.T. Pedicle Screw System, Medacta International (2016) Summary page 4.
- K121115: M.U.S.T Pedicle Screw System, Medacta International (2012) Summary page 4.
- K132878: M.U.S.T. Extension, Medacta International (2013) Summary page 4.
- K141988: M.U.S.T Pedicle Screw System, Medacta International (2014) Summary page 4.
- K162061: M.U.S.T. Pedicle Screw System, Medacta International S.A. (2016) 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.
- K171758: M.U.S.T. Combined Set Screws, Medacta International S.A. (2017) Summary page 4.
- K193365: M.U.S.T. Pedicle Screw System, Medacta International S.A. (2020) Summary page 4.

## Most influential descendants
- 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
- K252885: OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (2026), 0 descendants of its own

## 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/K203482
Methodology: https://510kreport.com/methodology