# K052404: Denali Deformity System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, LLC
- Decided: May 23, 2006 after 264 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
75 later devices descend from it; 5 cite it directly.
0 of 76 devices in its family (counting itself) have 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) Xia Spine System: named in the summary without a submission number
- (no number) Denali Spine System: named in the summary without a submission number
- (no number) CD Horizon Legacy 5.5mm Spinal System: named in the summary without a submission number

## Most influential descendants
- K072914: Natural Bridge LP Transverse Connectors (2008), 65 descendants of its own
- K120099: Range Spinal System (Mesa and Denali) (2012), 53 descendants of its own
- K120656: Everest Spinal System (2012), 43 descendants of its own
- K132757: Everest Spinal System (2013), 41 descendants of its own
- K121016: Range Spinal System (Mesa and Denali) (2012), 38 descendants of its own

## Indications for use
The Denali Deformity 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 Denali Deformity 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-S I 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/K052404
Methodology: https://510kreport.com/methodology