# K112684: Mont Blanc Pedicle Screw Systems

- Pathway: 510(k) (Traditional)
- Applicant: Qualgenix
- Decided: May 1, 2012 after 229 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: 3 generations back to K901587 (1990). 21 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962628: Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 2.
- K973836: Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System, Cross Medical Products, Inc. (1998) Summary page 2.
- K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 2.
- K993067: Silhouette Spinal Fixation System, Sulzer Spine-Tech (1999) Summary page 2.

## Most influential descendants
- K150185: Mont Blanc Spinal System (2015), 4 descendants of its own
- K161387: Mont Blanc and Mont Blanc MIS Spinal Systems (2016), 3 descendants of its own
- K253045: “Socko” Vimax Spinal Fixation System (2026), 0 descendants of its own
- K231658: VEOS Spinal Fixation System (2023), 0 descendants of its own
- K191726: mont blanc & mont blanc MIS Spinal Systems (2019), 0 descendants of its own

## Indications for use
The Mont Blanc Pedicle Screw System is intended for noncervical pedicle fixation from the Ti to Si vertebrae in skeletally mature patients as an adjunct to fusion 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 failed previous fusion.

Source page: https://510kreport.com/device/K112684
Methodology: https://510kreport.com/methodology