# K121630: Range Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Sep 11, 2012 after 99 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: 12 generations back to K040583 (2004). 152 ancestors in all.
127 later devices descend from it; 12 cite it directly.
0 of 280 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 1.
- K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1.
- K071668: Orthobiom Spinal System, Paradigm Spine (2008) 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) Summary page 1.
- K111457: CD Horizon Spinal System, Medtronic Sofamor Danek (2011) Summary page 1.
- K111510: CD Horizon Spinal System, Medtronic Sofamor Danek, 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.
- K113529: CD Horizon Voyager Spinal System, Medtronic Sofamor Danek (2012) Summary page 1.
- K120291: OP Spine System, OrthoPediatrics Corp. (2012) Summary page 1.

## Cited in the summary but kept off the family tree
- K112555: CD Horizon (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K130932: Firebird Spinal Fixation System (2013), 81 descendants of its own
- K151488: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (2015), 78 descendants of its own
- K153428: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System (2016), 73 descendants of its own
- K171082: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System (2017), 61 descendants of its own
- K132757: Everest Spinal System (2013), 41 descendants of its own

## Indications for use
RANGE/ DENALY MESA and ARI are cleared for the following 'indicatipns: 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-S1 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 ofa solid fusion. Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletaily mature patients, for the following indications: degenerative disc disease (DDD ) (défined 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/K121630
Methodology: https://510kreport.com/methodology