# K141873: Range/Mesa/Denali Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Sep 8, 2014 after 59 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: 17 generations back to K853033 (1985). 311 ancestors in all.
30 later devices descend from it; 7 cite it directly.
0 of 342 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 4.
- K121630: Range Spinal System, K2m, Inc. (2012) Summary page 4.
- K133944: Range, Spinal System, Everest Spinal System, K2m, Inc. (2014) Summary page 4.
- K061017: Easyspine System, Ldr Spine USA (2006) Summary page 4.

## Most influential descendants
- K143334: Range/Denali/Mesa Spinal System (2015), 16 descendants of its own
- K171832: Range/Denali/Mesa Spinal System (2017), 13 descendants of its own
- K150325: Range/Denali/Mesa Spinal System (2015), 12 descendants of its own
- K151727: Everest Spinal System (2015), 11 descendants of its own
- K161369: EVEREST Spinal System (2016), 9 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 stcnosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pscudarthrosis: and/or failed previous fusion. Except for hooks, when used as an anterolatcral 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 noncervical 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/K141873
Methodology: https://510kreport.com/methodology