# K120099: Range Spinal System (Mesa and Denali)

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: May 18, 2012 after 127 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: 7 generations back to K950697 (1995). 44 ancestors in all.
53 later devices descend from it; 10 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042635: Denali Spine System, K2m, LLC (2005) Summary page 1.
- K052398: Mesa Spinal System, K2m, LLC (2005) 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.
- K110991: Mesa Spinal System (Keystone Rods), K2m, Inc. (2011)
- K112037: Range Spinal System (Mesa and Denali), K2m, Inc. (2011)
- K090230: Expedium Spine System, Depuy Spine, Inc. (2009) Summary page 1.
- K020709: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.

## Most influential descendants
- K130330: Range Spinal System (2013), 36 descendants of its own
- K132361: Everest Spinal System (2013), 34 descendants of its own
- K131784: Range Spinal System (2013), 34 descendants of its own
- K131030: Range Spinal System (2013), 34 descendants of its own
- K122877: Range Spinal System, Small Stature (2013), 34 descendants of its own

## Indications for use
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the AMI Anterior Vertebral Body Staples. The Range 4.5mm Small Stature Rod System is indicated for the following: 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-S1I 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 in skeletally mature patients.

Source page: https://510kreport.com/device/K120099
Methodology: https://510kreport.com/methodology