510(k) Report

510(k) · Cleared

Cleared

Denali Spine System

K042635510(k) TraditionalCleared Jan 10, 2005105-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

K2m, LLC · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jan 10, 2005 after a 105-day review. The FDA summary names its predicate without a number. 115 later devices descend from it.

Decided
Jan 10, 2005
Review
105 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

115 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2012: 7 descendants cleared2008: 1 descendant cleared2009: 2 descendants cleared2014: 6 descendants cleared2011: 3 descendants cleared2010: 4 descendants cleared2013: 11 descendants cleared2017: 10 descendants cleared2016: 9 descendants cleared2022: 4 descendants cleared2015: 11 descendants cleared2024: 9 descendants cleared2025: 3 descendants cleared2023: 10 descendants cleared2020: 5 descendants cleared2018: 11 descendants cleared2026: 5 descendants cleared2021: 4 descendants cleared20052010201520202025
  1. This deviceK042635 Denali Spine SystemK2m, LLC · 2005
  2. Descendant · cites it directly · 65 of its ownK112037 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
  3. Descendant · cites it directly · 65 of its ownK072914 Natural Bridge LP Transverse ConnectorsK2m, Inc. · 2008
  4. Descendant · cites it directly · 53 of its ownK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  5. Descendant · 2 generations on · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
  6. Descendant · 2 generations on · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013

Showing 5 of 115 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22010: 42011: 32012: 72013: 112014: 62015: 112016: 92017: 102018: 112020: 52021: 42022: 42023: 102024: 92025: 32026: 5
2008high 11 (2013) · low 0 (2019)2026

Most influential descendants

Showing 5 of 115 · See all
  • K112037Range Spinal System (Mesa and Denali)K2m, Inc. · 2011 · cites it directly65descendants
  • K072914Natural Bridge LP Transverse ConnectorsK2m, Inc. · 2008 · cites it directly65descendants
  • K120099Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · cites it directly53descendants
  • K120656Everest Spinal SystemK2m, Inc. · 2012 · 2 generations on43descendants
  • K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042635Denali Spine SystemK2m, LLC2005—
+1K112037Range Spinal System (Mesa and Denali)K2m, Inc.2011—
+1K072914Natural Bridge LP Transverse ConnectorsK2m, Inc.2008—
+1K120099Range Spinal System (Mesa and Denali)K2m, Inc.2012—
+2K120656Everest Spinal SystemK2m, Inc.2012—
+2K132757Everest Spinal SystemK2m, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201040
201130
201270
2013110
201460
2015110
201690
2017100
2018110
202050
202140
202240
2023100
202490
202530
202650
FIG. 1 — Lineage of K042635, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Xia Spine System
Named without a submission number
—
*—Global Spine Fixation System
Named without a submission number
—
*—CD Horizon Spinal System
Named without a submission number
—

What descends from it? (115)

See all 115

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165
K072914Natural Bridge LP Transverse ConnectorsK2m, Inc.200865
K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253
K081153Novel Spinal SystemMedyssey Co, Ltd.200923
K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415
K122332Towerlox Pedicle Screw SystemCaptiva Spine201214
K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098
K101112Reliance Spinal Screw SystemReliance Medical Systems20107
K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125

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, K112037 (K2m, Inc., 2011) has gone furthest, with 65 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

The Denali 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…

Read the full statement (148 words)

The Denali 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 Denali 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.

Indications for use as stated in the FDA summary.

More from K2m, LLC

8 FDA decisions under this applicant name. See the company

  • K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
  • K140529Everest Spinal SystemK2m, LLC · 2014
  • K052404Denali Deformity SystemK2m, LLC · 2006
  • K060442Pyrenees Cervical Plate SystemK2m, LLC · 2006
  • K052398Mesa Spinal SystemK2m, LLC · 2005

Recent decisions in KWP

The KWP category page

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  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
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https://510kreport.com/device/K042635 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042635: Denali Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042635

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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