# K140529: Everest Spinal System

- Pathway: 510(k) (Special)
- Applicant: K2m, LLC
- Decided: May 22, 2014 after 79 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: 14 generations back to K853033 (1985). 256 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103440: Everest Spinal System, K2m, Inc. (2011) Summary page 1.
- K120656: Everest Spinal System, K2m, Inc. (2012) Summary page 1.
- K132757: Everest Spinal System, K2m, Inc. (2013) Summary page 1.
- K070229: Range Spinal System, K2m, Inc. (2007) Summary page 1.
- K072914: Natural Bridge LP Transverse Connectors, K2m, Inc. (2008) Summary page 1.
- K080792: K2M Cocr Rod, K2m, Inc. (2008) Summary page 1.
- K081381: Range Spinal System, Large Denali Screws, K2m, Inc. (2008) Summary page 1.
- K100851: Range Spinal System, K2m, Inc. (2010) Summary page 1.
- K112037: Range Spinal System (Mesa and Denali), K2m, Inc. (2011)
- K112920: Range Spinal System (Mesa and Denali), K2m, Inc. (2011)
- K961633: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1996) Summary page 1.
- K090390: CD Horizon Spinal System, Medtronic Sofamor Danek (2009) Summary page 1.
- K132328: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 1.

## Most influential descendants
- K142360: Everest Spinal System (2015), 22 descendants of its own
- K143334: Range/Denali/Mesa Spinal System (2015), 16 descendants of its own
- K140765: Range/Mesa/Denali Spinal System (2014), 15 descendants of its own
- K171832: Range/Denali/Mesa Spinal System (2017), 13 descendants of its own
- K150325: Range/Denali/Mesa Spinal System (2015), 12 descendants of its own

## Indications for use
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications: Non-cervical fixation 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/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K140529
Methodology: https://510kreport.com/methodology