# K153031: RANGE/DENALI/MESA Spinal System

- Pathway: 510(k) (Special)
- Applicant: K2m, Incorporated
- Decided: Nov 17, 2015 after 29 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 19 generations back to K853033 (1985). 317 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 320 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143334: Range/Denali/Mesa Spinal System, K2m, Inc. (2015) Summary page 4.
- K070229: Range Spinal System, K2m, Inc. (2007) Summary page 4.
- K120899: Range Spinal System, Unit Rod, K2m, Inc. (2012) Summary page 4.
- K131030: Range Spinal System, K2m, Inc. (2013) Summary page 4.
- K141873: Range/Mesa/Denali Spinal System, K2m, Inc. (2014) Summary page 4.

## Most influential descendants
- K171321: K2M Navigation Instruments (2017), 1 descendant of its own
- K201006: K2M Navigation Instruments (2020), 0 descendants of its own

## Indications for use
RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudoarthosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion. Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K153031
Methodology: https://510kreport.com/methodology