# K241034: Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jun 12, 2024 after 57 days
- Product code: PML (Bone Cement, Posterior Screw Augmentation)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K040583 (2004). 170 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 173 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems, Medos International Sàrl (2016) Summary page 4.
- K203482: M.U.S.T. Pedicle Screw Extension and Long Tab Implants, Medacta International S.A. (2021) 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.
- K141988: M.U.S.T Pedicle Screw System, Medacta International (2014) Summary page 4.
- K132878: M.U.S.T. Extension, Medacta International (2013) Summary page 4.
- K121115: M.U.S.T Pedicle Screw System, Medacta International (2012) Summary page 4.
- K103433: F20, Teknimed, S.A. (2011) Summary page 4.

## Most influential descendants
- K260286: Dynamo™ Spinal Cement; Salvo® Spine System (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. Fenestrated Pedicle Screw System when used without cement 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.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in conjunction with Meta+ Spine cement, the M.U.S.T. Fenestrated Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. M.U.S.T. Fenestrated Pedicle Screw System augmented with Meta+ Spine cement is intended for use at spinal levels where the structural integrity of the spine is not severely compromised. Meta+ Spine cement, when used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. The M.U.S.T. Fenestrated Pedicle Screw System, augmented with Meta+ Spine Cement, is for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K241034
Methodology: https://510kreport.com/methodology