# K121115: M.U.S.T Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Jul 18, 2012 after 97 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K040583 (2004). 142 ancestors in all.
43 later devices descend from it; 13 cite it directly.
1 of 186 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.
- K042962: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 1.
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 1.
- K100952: Modification to Synthes Matrix System, Synthes Spine (2010) Summary page 1.
- K072022: Valeo Pedicle Screw Spinal System, Amedica Corp. (2007) Summary page 1.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K083393: Xia 3 Spinal System, Stryker Spine (2009) Summary page 1.
- K101074: Modification to: CD Horizon (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2010) Summary page 1.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 1.

## Most influential descendants
- K132878: M.U.S.T. Extension (2013), 28 descendants of its own
- K141988: M.U.S.T Pedicle Screw System (2014), 26 descendants of its own
- K153664: M.U.S.T. Pedicle Screw System (2016), 24 descendants of its own
- K171170: M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws (2017), 23 descendants of its own
- K141044: M.U.S.T. Extension (2014), 16 descendants of its own

## Recalls of this device
- Dec 7, 2016 · Class II · Z-1023-2017: Damaged packaging, lack of sterility assurance

## Indications for use
The M.U.S.T. pedlicle screw system is intended for posterior non-cervical pedicle fixation (Ti -S2/ilium) or anterolateral fixation (TB-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 lordlosis); tumor; pseudloarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K121115
Methodology: https://510kreport.com/methodology