# K042210: MSD Silo Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Nov 4, 2004 after 80 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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: 2 generations back to K981676 (1999). 3 ancestors in all.
666 later devices descend from it; 2 cite it directly.
1 of 670 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041030: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.

## Most influential descendants
- K052144: TSRH Spinal System (2005), 665 descendants of its own
- K090390: CD Horizon Spinal System (2009), 663 descendants of its own
- K091974: Modification to CD Horizon Spinal System (2009), 656 descendants of its own
- K102555: CD Horizon Spinal System (2010), 598 descendants of its own
- K112473: CD Horizon Spinal System (2011), 597 descendants of its own

## Recalls of this device
- Dec 18, 2006 · Not classified · Z-0411-2007: Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use.

## Indications for use
The MSD SiLoTM System is intended for posterior, non-cervical fixation for 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; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the MSD SiLoTM components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

Source page: https://510kreport.com/device/K042210
Methodology: https://510kreport.com/methodology