# K181119: Range (Denali and Mesa) Spinal Systems

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Jun 26, 2018 after 60 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). 398 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 404 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171832: Range/Denali/Mesa Spinal System, K2m, Inc. (2017) Summary page 4.
- K173508: Everest Spinal System, K2m (2018) Summary page 4.

## Most influential descendants
- K232341: CarboClear® Pedicle Screw System (2023), 4 descendants of its own
- K233944: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (2024), 3 descendants of its own
- K240846: CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement (2024), 2 descendants of its own
- K233793: CarboClear® X Pedicle Screw System (2024), 1 descendant of its own
- K243106: CarboClear® Hybrid Pedicle Screw System (2024), 0 descendants of its own

## Indications for use
The MESA and DENALL Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications: Posterior 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 MESA, DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST 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/K181119
Methodology: https://510kreport.com/methodology