# K072022: Valeo Pedicle Screw Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Corp.
- Decided: Nov 19, 2007 after 119 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: 4 generations back to K000319 (2000). 32 ancestors in all.
100 later devices descend from it; 7 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K042962: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K033495: Modification to Equation Fixation System, Medtronic Sofamor Danek, Inc. (2003) Summary page 2.
- K042453: Modification to Equation Fixation System, Medtronic Sofamor Danek, Inc. (2004) Summary page 2.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K962628: Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 2.
- K071857: Delta Spinal Fusion System, Jemo Spine, LLC (2007). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K121115: M.U.S.T Pedicle Screw System (2012), 43 descendants of its own
- K151977: icotec Pedicle System (2016), 30 descendants of its own
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own
- K132878: M.U.S.T. Extension (2013), 28 descendants of its own
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own

## Indications for use
The ValeoTM Pedicle Screw System is intended for noncervical pedicle fixation from the TI to L5 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/K072022
Methodology: https://510kreport.com/methodology