# K162232: MOSS 100 Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Biedermann Motech GmbH & Co. KG
- Decided: Nov 17, 2016 after 101 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: 2 generations back to K033901 (2004). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 5.

## Most influential descendants
- K181821: MOSS VRS Spinal System (2018), 1 descendant of its own
- K203607: MOSS VRS Spinal System (2021), 0 descendants of its own

## Indications for use
The MOSS 100 Pedicle Screw System is a thoracolumbar pedicle fixation device for the following indications of use: - Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - Trauma (i.e. fractures or dislocations) - Spinal Stenosis - Curvatures (i.e. scoliosis, kyphoses and/ or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion

Source page: https://510kreport.com/device/K162232
Methodology: https://510kreport.com/methodology