# K132361: Everest Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Oct 3, 2013 after 65 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 15 generations back to K853033 (1985). 295 ancestors in all.
34 later devices descend from it; 1 cites it directly.
0 of 330 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.
- K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 1.
- K070229: Range Spinal System, K2m, Inc. (2007) 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.
- K112037: Range Spinal System (Mesa and Denali), K2m, Inc. (2011)
- K130330: Range Spinal System, K2m, Inc. (2013)
- K092287: Nuvasive Spherx II - Pedicle Screw System, Nuvasive, Inc. (2009) Summary page 1.
- K083416: Revolve Stabilization System, Globus Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K133944: Range, Spinal System, Everest Spinal System (2014), 33 descendants of its own
- K141873: Range/Mesa/Denali Spinal System (2014), 30 descendants of its own
- K143334: Range/Denali/Mesa Spinal System (2015), 16 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 RANGlE (MESA" and DENALI ) Spinal Systems, all of which are cleared for the following indications: Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthbrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion. Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (defined as back pain of discagenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; traumna ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K132361
Methodology: https://510kreport.com/methodology