510(k) · Cleared
ClearedDenali Deformity System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, LLC · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on May 23, 2006 after a 264-day review. The FDA summary names its predicate without a number. 75 later devices descend from it.
- Decided
- May 23, 2006
- Review
- 264 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
75 later devices descend from it, 5 citing it directly.
- This deviceK052404 Denali Deformity SystemK2m, LLC · 2006
- Descendant · cites it directly · 65 of its ownK072914 Natural Bridge LP Transverse ConnectorsK2m, Inc. · 2008
- Descendant · 2 generations on · 53 of its ownK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- Descendant · 2 generations on · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
- Descendant · 2 generations on · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 38 of its ownK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K072914Natural Bridge LP Transverse ConnectorsK2m, Inc. · 2008 · cites it directly65descendants
- K120099Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · 2 generations on53descendants
- K120656Everest Spinal SystemK2m, Inc. · 2012 · 2 generations on43descendants
- K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
- K121016Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · 2 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052404 | Denali Deformity System | K2m, LLC | 2006 | — |
| +1 | K072914 | Natural Bridge LP Transverse Connectors | K2m, Inc. | 2008 | — |
| +2 | K120099 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| +2 | K120656 | Everest Spinal System | K2m, Inc. | 2012 | — |
| +2 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +2 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 8 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Xia Spine System Named without a submission number | |
| * | — | Denali Spine System Named without a submission number | |
| * | — | CD Horizon Legacy 5.5mm Spinal System Named without a submission number |
What descends from it? (75)
See all 755 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072914 (K2m, Inc., 2008) has gone furthest, with 65 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (149 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052404: Denali Deformity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052404
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026