510(k) Report

510(k) · Cleared

Cleared

Range Spinal System, Large Denali Screws

K081381510(k) SpecialCleared Jun 13, 200828-day reviewClass II21 CFR 888.3070

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

K2m, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jun 13, 2008 after a 28-day review. The FDA summary names its predicate without a number. 67 later devices descend from it.

Decided
Jun 13, 2008
Review
28 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

67 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2012: 5 descendants cleared2011: 2 descendants cleared2013: 7 descendants cleared2014: 6 descendants cleared2024: 7 descendants cleared2015: 8 descendants cleared2018: 7 descendants cleared2017: 7 descendants cleared2016: 4 descendants cleared2026: 4 descendants cleared2025: 1 descendant cleared2022: 2 descendants cleared2021: 1 descendant cleared2020: 2 descendants cleared2023: 4 descendants cleared20052010201520202025
  1. This deviceK081381 Range Spinal System, Large Denali ScrewsK2m, Inc. · 2008
  2. Descendant · cites it directly · 65 of its ownK112037 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
  3. Descendant · 2 generations on · 53 of its ownK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  4. Descendant · cites it directly · 49 of its ownK112920 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
  5. Descendant · cites it directly · 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 67 descendants. See all descendants

Descendants cleared per year

2011: 22012: 52013: 72014: 62015: 82016: 42017: 72018: 72020: 22021: 12022: 22023: 42024: 72025: 12026: 4
2011high 8 (2015) · low 0 (2019)2026

Most influential descendants

Showing 5 of 67 · See all
  • K112037Range Spinal System (Mesa and Denali)K2m, Inc. · 2011 · cites it directly65descendants
  • K120099Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · 2 generations on53descendants
  • K112920Range Spinal System (Mesa and Denali)K2m, Inc. · 2011 · cites it directly49descendants
  • K120656Everest Spinal SystemK2m, Inc. · 2012 · cites it directly43descendants
  • K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K081381Range Spinal System, Large Denali ScrewsK2m, Inc.2008—
+1K112037Range Spinal System (Mesa and Denali)K2m, Inc.2011—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.2012—
+1K112920Range Spinal System (Mesa and Denali)K2m, Inc.2011—
+1K120656Everest Spinal SystemK2m, Inc.2012—
+2K132757Everest Spinal SystemK2m, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201250
201370
201460
201580
201640
201770
201870
202020
202110
202220
202340
202470
202510
202640
FIG. 1 — Lineage of K081381, 2008–2026Source: 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 MNH? 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? (1)

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
*—Expedium
Named without a submission number
—

What descends from it? (67)

See all 67

8 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
K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149
K120656Everest Spinal SystemK2m, Inc.201243
K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238
K120899Range Spinal System, Unit RodK2m, Inc.201235
K132361Everest Spinal SystemK2m, Inc.201334
K131030Range Spinal SystemK2m, Inc.201334
K140529Everest Spinal SystemK2m, LLC201431

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 MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

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.…

Read the full statement (134 words)

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.

Indications for use as stated in the FDA summary.

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

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  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K081381 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081381: Range Spinal System, Large Denali Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081381

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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