# K133944: Range, Spinal System, Everest Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Mar 21, 2014 after 88 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: 16 generations back to K853033 (1985). 307 ancestors in all.
33 later devices descend from it; 3 cite it directly.
0 of 341 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032033: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.
- K070229: Range Spinal System, K2m, Inc. (2007) Summary page 1.
- K121630: Range Spinal System, K2m, Inc. (2012). Our reading of the summary gave K121639, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “K2M Range Spinal System”.
- K122877: Range Spinal System, Small Stature, K2m, Inc. (2013) Summary page 1.
- K123412: Range Spinal System, Small Strature Components, K2m, Inc. (2013) Summary page 1.
- K130330: Range Spinal System, K2m, Inc. (2013) Summary page 1.
- K131030: Range Spinal System, K2m, Inc. (2013) Summary page 1.
- K131784: Range Spinal System, K2m, Inc. (2013) Summary page 1.
- K103440: Everest Spinal System, K2m, Inc. (2011) Summary page 1.
- K120656: Everest Spinal System, K2m, Inc. (2012) Summary page 1.
- K132361: Everest Spinal System, K2m, Inc. (2013) Summary page 1.
- K132757: Everest Spinal System, K2m, Inc. (2013) Summary page 1.

## Most influential descendants
- K141873: Range/Mesa/Denali Spinal System (2014), 30 descendants of its own
- 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

## Indications for use
RANGE /DENALI/MESA and SMALL STATURE and AR! 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 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 allogiraft Pediatric pedicle screw fixation is limited to a posterior approach. The EVEREST Spinal System may be used in conjunction with the RANGE's(EA and DENALfl Spinal Systems, all of which 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 railed previous fusion. Except for hooks, when used as an anterolatcral thoracic/lumbar system the Everest Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pcdicle screw fixation in pediatric patients the Everest Spinal System implants arc indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices arc to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K133944
Methodology: https://510kreport.com/methodology