# K080792: K2M Cocr Rod

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Apr 8, 2008 after 19 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
Longest line of descent: 1 generation back to K070229 (2007). 1 ancestor in all.
596 later devices descend from it; 18 cite it directly.
1 of 598 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070229: Range Spinal System, K2m, Inc. (2007) Summary page 4.
- (no number) Xia Spinal System: named in the summary without a submission number
- (no number) Quantum Spinal System: named in the summary without a submission number
- (no number) CD Horizon Spinal System: named in the summary without a submission number

## Most influential descendants
- 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
- K101070: Expedium Spine System (2010), 260 descendants of its own

## Indications for use
The Range Spinal System (K070229) is cleared for the following indications: Non-cervical spinal fixation devices 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. 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/K080792
Methodology: https://510kreport.com/methodology