# K122877: Range Spinal System, Small Stature

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: May 8, 2013 after 231 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: 13 generations back to K040583 (2004). 185 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120099: Range Spinal System (Mesa and Denali), K2m, Inc. (2012) Summary page 1.
- K121630: Range Spinal System, K2m, Inc. (2012) Summary page 1.
- K090230: Expedium Spine System, Depuy Spine, Inc. (2009) Summary page 1.
- K111136: Expedium Spine System, Viper System, Viper 2 System, Depuy Spine, Inc. (2012)
- K020709: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.
- K102555: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2010) Summary page 1.
- K102807: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2010) Summary page 1.
- K110070: TSRH Spinal System, Medtronic Sofamor Danck USA, Inc. (2011) Summary page 1.
- K111942: TSRH Spinal Systems, Medtronic Sofamor Danek USA, Inc. (2011)
- K111510: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2011)
- K111457: CD Horizon Spinal System, Medtronic Sofamor Danek (2011)
- K112555: CD Horizon (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 1.
- K112473: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2011) Summary page 1.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) 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 AR] 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 LS-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 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/K122877
Methodology: https://510kreport.com/methodology