# K112037: Range Spinal System (Mesa and Denali)

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Oct 6, 2011 after 80 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: 3 generations back to K032265 (2003). 11 ancestors in all.
65 later devices descend from it; 7 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 1.
- K080611: Mesa Spinal System, K2m, Inc. (2009) Summary page 1.
- K042635: Denali Spine System, K2m, LLC (2005) Summary page 1.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K120099: Range Spinal System (Mesa and Denali) (2012), 53 descendants of its own
- K120656: Everest Spinal System (2012), 43 descendants of its own
- K132757: Everest Spinal System (2013), 41 descendants of its own
- K121016: Range Spinal System (Mesa and Denali) (2012), 38 descendants of its own
- K130330: Range Spinal System (2013), 36 descendants of its own

## Indications for use
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, 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; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-SI 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, kyphasis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K112037
Methodology: https://510kreport.com/methodology