# K120656: Everest Spinal System

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Apr 4, 2012 after 30 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: 12 generations back to K853033 (1985). 113 ancestors in all.
43 later devices descend from it; 4 cite it directly.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081107: Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors, K2m, Inc. (2008) 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)
- K112037: Range Spinal System (Mesa and Denali), K2m, Inc. (2011)
- K112920: Range Spinal System (Mesa and Denali), K2m, Inc. (2011)
- K092540: C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody Spacer, Rsb Spine, LLC (2010) Summary page 1.
- K093534: Modification to Caspian Spinal System, K2m, Inc. (2009) Summary page 1.
- K103232: Caspian Spinal System, K2m, Inc. (2011) Summary page 1.
- K113654: Caspian, K2m, Inc. (2012)
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011) Summary page 1.

## Most influential descendants
- K132757: Everest Spinal System (2013), 41 descendants of its own
- K132361: Everest Spinal System (2013), 34 descendants of its own
- K133944: Range, Spinal System, Everest Spinal System (2014), 33 descendants of its own
- K140529: Everest Spinal System (2014), 31 descendants of its own
- K141873: Range/Mesa/Denali Spinal System (2014), 30 descendants of its own

## Indications for use
The Everest Spinal System if used in conjunction with the Range (Mesa and Denali) Spinal Systems are: 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, kyphiosis; and/ar lordosis); tumor; pseudoarthrosis; 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 thoracolumnbar screw stabilization as an adjunct to fbision for the following indications: degenerative disc disease (DDD ) (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, .yphosis; and/or lordosis); tumor; pscudoartbrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K120656
Methodology: https://510kreport.com/methodology