# K073430: Valeo Pedicle Screw Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Corp.
- Decided: Jan 29, 2008 after 54 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: 10 generations back to K853033 (1985). 139 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071857: Delta Spinal Fusion System, Jemo Spine, LLC (2007) Summary page 2.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003)
- K070387: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 2.
- K072317: Modification to:TSRH Spinal System, Medtronic Sofamor Danek USA, Inc. (2007) Summary page 2.
- K072183: ST360 Spinal Fixation System, Model 07.0029-7500.5600, Zimmer Spine, Inc. (2007) Summary page 2.
- K070962: Coral Pedicle Screw System, Theken Spine, LLC (2007) Summary page 2.
- K071860: Modification to: Viper Spine System, Depuy Spine, Inc. (2007) Summary page 2.
- K071376: Modification to Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2007) Summary page 2.
- K070281: Issys LP Spinal Fixation System, Custom Spine, Inc. (2007) Summary page 2.
- K062685: Ebi Aray Spinal System, Ebi, L.P. (2006) Summary page 2.
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 2.
- K072022: Valeo Pedicle Screw Spinal System, Amedica Corp. (2007) Summary page 2.

## Most influential descendants
- K080767: Conquest Spinal System (2008), 21 descendants of its own
- K123373: Nautilus Spinal System (2013), 17 descendants of its own
- K132760: Nautilus Spinal System (2013), 14 descendants of its own
- K141222: Nautilus Spinal System and Solstice Oct System (2015), 13 descendants of its own
- K133564: Modification to Nautilus Spinal System (2014), 13 descendants of its own

## Indications for use
The ValeoTM Pedicle Screw System is intended for noncervical pedicle fixation and noncervical nonpedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the Ti-Si vertebrae in skeletally mature patients: 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/K073430
Methodology: https://510kreport.com/methodology