510(k) Report

510(k) · Cleared

Cleared

Range Spinal System (Mesa and Denali)

K112037510(k) SpecialCleared Oct 6, 201180-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. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Oct 6, 2011 as substantially equivalent to K070229 (K2m, Inc., 2007) and 6 other predicates after an 80-day review. Its family tree reaches back 3 generations to 2003. 65 later devices descend from it.

Decided
Oct 6, 2011
Review
80 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K032265 (2003). 11 ancestors in all. 65 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 2 other ancestors2007: 1 other ancestor2005: 2 other ancestors2004: 1 other ancestor2003: 1 other ancestor2012: 5 descendants cleared2013: 7 descendants cleared2014: 6 descendants cleared2015: 8 descendants cleared2017: 7 descendants cleared2016: 4 descendants cleared2018: 7 descendants cleared2026: 4 descendants cleared2024: 7 descendants cleared2025: 1 descendant cleared2022: 2 descendants cleared2021: 1 descendant cleared2023: 4 descendants cleared2020: 2 descendants clearedK032265 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2003K041801 · Expedium Mis Spine System · Depuy Spine, Inc. · 2004K061520 · Viper Spine System · Depuy Spine, Inc. · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors3 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 17 descendants3 generations forward: 18 descendants4 generations forward: 13 descendants5 generations forward: 6 descendants6 generations forward: 4 descendants K061520 · Viper Spine System · Depuy Spine, Inc. · 2006K041801 · Expedium Mis Spine System · Depuy Spine, Inc. · 2004K032265 · CD Horizon Spinal System · Medtronic Sofamor Danek · 20030+5
  1. Root · 3 generations backK032265 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2003
  2. 2 generations backK041801 Expedium Mis Spine SystemDepuy Spine, Inc. · 2004
  3. 1 generation backK061520 Viper Spine SystemDepuy Spine, Inc. · 2006
  4. This deviceK112037 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
  5. Descendant · cites it directly · 53 of its ownK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  6. Descendant · cites it directly · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
  7. Descendant · 2 generations on · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
  8. Descendant · cites it directly · 38 of its ownK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  9. Descendant · 2 generations on · 36 of its ownK130330 Range Spinal SystemK2m, Inc. · 2013

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2012: 52013: 72014: 62015: 82016: 42017: 72018: 72020: 22021: 12022: 22023: 42024: 72025: 12026: 4
2012high 8 (2015) · low 0 (2019)2026

Most influential descendants

Showing 5 of 65 · See all
  • K120099Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · cites it directly53descendants
  • K120656Everest Spinal SystemK2m, Inc. · 2012 · cites it directly43descendants
  • K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
  • K121016Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · cites it directly38descendants
  • K130330Range Spinal SystemK2m, Inc. · 2013 · 2 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K032265CD Horizon Spinal SystemMedtronic Sofamor Danek2003—
−2K041801Expedium Mis Spine SystemDepuy Spine, Inc.2004—
−1K061520Viper Spine SystemDepuy Spine, Inc.2006—
0 (this device)K112037Range Spinal System (Mesa and Denali)K2m, Inc.2011—
+1K120099Range Spinal System (Mesa and Denali)K2m, Inc.2012—
+1K120656Everest Spinal SystemK2m, Inc.2012—
+2K132757Everest Spinal SystemK2m, Inc.2013—
+1K121016Range Spinal System (Mesa and Denali)K2m, Inc.2012—
+2K130330Range Spinal SystemK2m, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200520
200710
200820
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201250
201370
201460
201580
201640
201770
201870
202020
202110
202220
202340
202470
202510
202640
FIG. 1 — Lineage of K112037, 2003–2026Source: 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 MNI? 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
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What was it cleared against? (7)

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
*K070229Range Spinal System
Summary page 1
…MNI, KWP, MN!] Regulatory Class: Class II 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K070229, K080792, K08 1381) " K2M Mesa Spinal System (K(052398, K08061 1) * K2M Denali Spinal System (K(042635) * DePuy Viper…
K2m, Inc.2007—
*K080792K2M Cocr Rod
Summary page 1
…MN!] Regulatory Class: Class II 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K070229, K080792, K08 1381) " K2M Mesa Spinal System (K(052398, K08061 1) * K2M Denali Spinal System (K(042635) * DePuy Viper (K061520…
K2m, Inc.2008—
*K081381Range Spinal System, Large Denali Screws
Summary page 1
…egulatory Class: Class II 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K070229, K080792, K08 1381) " K2M Mesa Spinal System (K(052398, K08061 1) * K2M Denali Spinal System (K(042635) * DePuy Viper (K061520) 4. Des…
K2m, Inc.2008—
*K052398Mesa Spinal System
Summary page 1
…3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K070229, K080792, K08 1381) " K2M Mesa Spinal System (K(052398, K08061 1) * K2M Denali Spinal System (K(042635) * DePuy Viper (K061520) 4. Description of the device: The Rang…
K2m, LLC2005—
*K080611Mesa Spinal System
Summary page 1
…dicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K070229, K080792, K08 1381) " K2M Mesa Spinal System (K(052398, K08061 1) * K2M Denali Spinal System (K(042635) * DePuy Viper (K061520) 4. Description of the device: The Range Spinal S…
K2m, Inc.2009—
*K042635Denali Spine System
Summary page 1
…substantially equivalent: * K2M Range Spinal System (K070229, K080792, K08 1381) " K2M Mesa Spinal System (K(052398, K08061 1) * K2M Denali Spinal System (K(042635) * DePuy Viper (K061520) 4. Description of the device: The Range Spinal System is a top-loading, multiple component…
K2m, LLC2005—
*K061520Viper Spine System
Summary page 1
…* K2M Range Spinal System (K070229, K080792, K08 1381) " K2M Mesa Spinal System (K(052398, K08061 1) * K2M Denali Spinal System (K(042635) * DePuy Viper (K061520) 4. Description of the device: The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar…
Depuy Spine, Inc.2006—

Also cleared against K070229: 23 other devices →

What descends from it? (65)

See all 65

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

NumberDeviceApplicantDecidedDescendants
K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253
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?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • None of the 11 ancestors has a recall.
  • Of its descendants, K120099 (K2m, Inc., 2012) has gone furthest, with 53 descendants of its own.
  • 23 other devices also cite its predicate K070229.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications: Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor…

Read the full statement (193 words)

The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion 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-SI 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion 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, kyphasis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K070229

23 other devices cite the same predicate.

  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K171832Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
  • K171321K2M Navigation InstrumentsK2m · 20171 recall
  • K161028K2M Growing Spine SystemK2m, Inc. · 2016
  • K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated · 2015
  • K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

  • K260546Q Pedicle InstrumentsK2m, Inc. · 2026
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026
  • K252873Q Interbody InstrumentsK2m, Inc. · 2026
  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K112037 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112037: Range Spinal System (Mesa and Denali).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112037

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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