# K103440: Everest Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Mar 17, 2011 after 114 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
No predicates in its family tree.
43 later devices descend from it; 8 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) K2M Range Spinal System: named in the summary without a submission number
- (no number) K2M Mesa Spinal System: named in the summary without a submission number
- (no number) K2M Denali Spinal System: named in the summary without a submission number
- (no number) Stryker Xia: named in the summary without a submission number

## 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 is a non-cervical, pedicle screw fixation device 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); tmhnor; 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 thoracolumbar screw stabilization as an adjunct to fusion 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, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K103440
Methodology: https://510kreport.com/methodology