# K140765: Range/Mesa/Denali Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Jul 10, 2014 after 105 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: 15 generations back to K853033 (1985). 257 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 273 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 1.
- K042635: Denali Spine System, K2m, LLC (2005) Summary page 1.
- K070229: Range Spinal System, K2m, Inc. (2007) Summary page 1.
- K121630: Range Spinal System, K2m, Inc. (2012) Summary page 1.
- K140529: Everest Spinal System, K2m, LLC (2014). Cleared while this submission was under review Summary page 1.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.

## Most influential descendants
- K171832: Range/Denali/Mesa Spinal System (2017), 13 descendants of its own
- K181603: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (2018), 5 descendants of its own
- K181119: Range (Denali and Mesa) Spinal Systems (2018), 5 descendants of its own
- K232341: CarboClear® Pedicle Screw System (2023), 4 descendants of its own
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (2023), 4 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); tumnor pseudarthrosis; and/or failed previous fiusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be wsed for the same indications as an adjunct to fusion. Except for the AR! 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/K140765
Methodology: https://510kreport.com/methodology