# K131030: Range Spinal System

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: May 9, 2013 after 27 days
- Product code: OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis)
- 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: 14 generations back to K853033 (1985). 124 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 159 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 1.
- K072914: Natural Bridge LP Transverse Connectors, K2m, Inc. (2008) Summary page 1.
- K080792: K2M Cocr Rod, K2m, Inc. (2008) Summary page 1.
- K081381: Range Spinal System, Large Denali Screws, K2m, Inc. (2008). Our reading of the summary gave K081301, 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”.
- K100851: Range Spinal System, K2m, Inc. (2010) Summary page 1.
- K112037: Range Spinal System (Mesa and Denali), K2m, Inc. (2011)
- K112920: Range Spinal System (Mesa and Denali), K2m, Inc. (2011)
- K120099: Range Spinal System (Mesa and Denali), K2m, Inc. (2012) Summary page 1.
- K121016: Range Spinal System (Mesa and Denali), K2m, Inc. (2012). Our reading of the summary gave K121061, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “K2M Range Spinal System”.
- K120899: Range Spinal System, Unit Rod, K2m, Inc. (2012) Summary page 1.
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K133944: Range, Spinal System, Everest Spinal System (2014), 33 descendants of its own
- 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

## Indications for use
RANGE /DENALI, MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-SlI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion. Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, for the following indications: degenerative disc disease (DDD ) (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; pseudoarthrosis; and failed previous 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/K131030
Methodology: https://510kreport.com/methodology