# K070229: Range Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: May 3, 2007 after 99 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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
No predicates in its family tree.
598 later devices descend from it; 24 cite it directly.
1 of 599 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Denali Spine System: named in the summary without a submission number
- (no number) Mesa Spinal System: named in the summary without a submission number

## Most influential descendants
- K080792: K2M Cocr Rod (2008), 596 descendants of its own
- K082942: Modfication to: Expedium Spine System (2008), 518 descendants of its own
- K090230: Expedium Spine System (2009), 462 descendants of its own
- K090648: Viper 2 System (2009), 337 descendants of its own
- K092473: Expedium Spine System (2009), 263 descendants of its own

## Indications for use
The Range Spinal System is a non-cervical spinal fixation device intended for posterior, non-pedicle fixation 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. The Range Spinal System is also intended for non-cervical pedicle screw fixation 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 of a solid fusion.

Source page: https://510kreport.com/device/K070229
Methodology: https://510kreport.com/methodology