510(k) Report

510(k) · Cleared

Cleared

Range Spinal System (Mesa and Denali)

K120099510(k) SpecialCleared May 18, 2012127-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 May 18, 2012 as substantially equivalent to K042635 (K2m, LLC, 2005) and 8 other predicates after a 127-day review. Its family tree reaches back 7 generations to 1995. 53 later devices descend from it.

Decided
May 18, 2012
Review
127 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
9

Its longest line of descent runs back 7 generations to K950697 (1995). 44 ancestors in all, the oldest K933881 (1994). 53 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2008: 4 other ancestors2007: 2 other ancestors2005: 5 other ancestors2002: 1 other ancestor2009: 1 other ancestor2006: 3 other ancestors2004: 6 other ancestors1998: 1 other ancestor1997: 1 other ancestor1994: 1 other ancestor2003: 4 other ancestors2001: 3 other ancestors1999: 1 other ancestor1996: 1 other ancestor2000: 1 other ancestor2013: 6 descendants cleared2015: 6 descendants cleared2017: 7 descendants cleared2012: 1 descendant cleared2016: 3 descendants cleared2014: 4 descendants cleared2024: 7 descendants cleared2018: 6 descendants cleared2021: 1 descendant cleared2023: 4 descendants cleared2020: 2 descendants cleared2022: 2 descendants cleared2026: 4 descendants clearedK950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995×2: 2 generations cleared close together, K050461 (2005), K052761 (2005) ×2: 2 generations cleared close together, K060361 (2006), K060979 (2006) ×2: 2 generations cleared close together, K082942 (2008), K090230 (2009) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 12 other ancestors3 generations back: 9 other ancestors4 generations back: 4 other ancestors5 generations back: 3 other ancestors6 generations back: 1 other ancestor 1 generation forward: 10 descendants2 generations forward: 14 descendants3 generations forward: 14 descendants4 generations forward: 9 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant K090230 · Expedium Spine System · Depuy Spine, Inc. · 2009K082942 · Modfication to: Expedium Spine System · Depuy Spine, Inc. · 2008K060979 · Xia Titanium and 4.5 Spinal Systems · Stryker Spine · 2006K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalledK052761 · Modification to: Xia 4.5 Spinal System · Stryker Spine · 2005K050461 · Xia 4.5 Spinal System · Stryker Spine · 2005K950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995−50+5
  1. Root · 7 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. 6 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. 5 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. 4 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. 3 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
  6. 2 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
  7. 1 generation backK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
  8. This deviceK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  9. Descendant · cites it directly · 36 of its ownK130330 Range Spinal SystemK2m, Inc. · 2013
  10. Descendant · 2 generations on · 34 of its ownK132361 Everest Spinal SystemK2m, Inc. · 2013
  11. Descendant · cites it directly · 34 of its ownK131784 Range Spinal SystemK2m, Inc. · 2013
  12. Descendant · cites it directly · 34 of its ownK131030 Range Spinal SystemK2m, Inc. · 2013
  13. Descendant · cites it directly · 34 of its ownK122877 Range Spinal System, Small StatureK2m, Inc. · 2013

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2012: 12013: 62014: 42015: 62016: 32017: 72018: 62020: 22021: 12022: 22023: 42024: 72026: 4
2012high 7 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 53 · See all
  • K130330Range Spinal SystemK2m, Inc. · 2013 · cites it directly36descendants
  • K132361Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on34descendants
  • K131784Range Spinal SystemK2m, Inc. · 2013 · cites it directly34descendants
  • K131030Range Spinal SystemK2m, Inc. · 2013 · cites it directly34descendants
  • K122877Range Spinal System, Small StatureK2m, Inc. · 2013 · cites it directly34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
−6K050461Xia 4.5 Spinal SystemStryker Spine2005—
−5K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
−4K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
−3K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006—
−2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008—
−1K090230Expedium Spine SystemDepuy Spine, Inc.2009—
0 (this device)K120099Range Spinal System (Mesa and Denali)K2m, Inc.2012—
+1K130330Range Spinal SystemK2m, Inc.2013—
+2K132361Everest Spinal SystemK2m, Inc.2013—
+1K131784Range Spinal SystemK2m, Inc.2013—
+1K131030Range Spinal SystemK2m, Inc.2013—
+1K122877Range Spinal System, Small StatureK2m, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199610
199710
199810
199910
200010
200130
200210
200340
200460
200550
200630
200720
200840
200910
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201360
201440
201560
201630
201770
201860
202020
202110
202220
202340
202470
202640
FIG. 1 — Lineage of K120099, 1995–2026Source: 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? (9)

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
*K042635Denali Spine System
Summary page 1
…MNI, KWP, MNH Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K042635, K052398, K070229, K072914, K080792, KI 10991, KI 12037) * DePuy Expedium (K090230) * Medtronic CD Legacy (K020709)…
K2m, LLC2005—
*K052398Mesa Spinal System
Summary page 1
…MNH Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K042635, K052398, K070229, K072914, K080792, KI 10991, KI 12037) * DePuy Expedium (K090230) * Medtronic CD Legacy (K020709) *K2M…
K2m, LLC2005—
*K070229Range Spinal System
Summary page 1
…gulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K042635, K052398, K070229, K072914, K080792, KI 10991, KI 12037) * DePuy Expedium (K090230) * Medtronic CD Legacy (K020709) *K2M Mesa Spi…
K2m, Inc.2007—
*K072914Natural Bridge LP Transverse Connectors
Summary page 1
…Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K042635, K052398, K070229, K072914, K080792, KI 10991, KI 12037) * DePuy Expedium (K090230) * Medtronic CD Legacy (K020709) *K2M Mesa Spinal Syste…
K2m, Inc.2008—
*K080792K2M Cocr Rod
Summary page 1
…Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K042635, K052398, K070229, K072914, K080792, KI 10991, KI 12037) * DePuy Expedium (K090230) * Medtronic CD Legacy (K020709) *K2M Mesa Spinal System (KI 110…
K2m, Inc.2008—
*K110991Mesa Spinal System (Keystone Rods)K2m, Inc.2011—
*K112037Range Spinal System (Mesa and Denali)K2m, Inc.2011—
*K090230Expedium Spine System
Summary page 1
…eted devices which are substantially equivalent * K2M Range Spinal System (K042635, K052398, K070229, K072914, K080792, KI 10991, KI 12037) * DePuy Expedium (K090230) * Medtronic CD Legacy (K020709) *K2M Mesa Spinal System (KI 11099 1) 4. Description of the device: The Ra…
Depuy Spine, Inc.2009—
*K020709Modification to CD Horizon Spinal System
Summary page 1
…quivalent * K2M Range Spinal System (K042635, K052398, K070229, K072914, K080792, KI 10991, KI 12037) * DePuy Expedium (K090230) * Medtronic CD Legacy (K020709) *K2M Mesa Spinal System (KI 11099 1) 4. Description of the device: The Range Spinal System is a top-loading, mu…
Medtronic Sofamor Danek2002—

Also cleared against K042635: 8 other devices →

What descends from it? (53)

See all 53

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

NumberDeviceApplicantDecidedDescendants
K130330Range Spinal SystemK2m, Inc.201336
K131784Range Spinal SystemK2m, Inc.201334
K131030Range Spinal SystemK2m, Inc.201334
K122877Range Spinal System, Small StatureK2m, Inc.201334
K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334
K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713
K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512
K143350Nile Alternative FixationK2m, Inc.201510
K122145Lanx Spinal Fixation SystemLanx, Inc.20127
K161028K2M Growing Spine SystemK2m, Inc.20163

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 17 years and passes through 4 companies; a new generation was cleared every 5 months on median.
  • 2 of the 44 ancestors have a recall of any class.
  • Of its descendants, K130330 (K2m, Inc., 2013) has gone furthest, with 36 descendants of its own.
  • 8 other devices also cite its predicate K042635.

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. 2012, 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 AMI Anterior Vertebral Body Staples. The Range 4.5mm Small Stature Rod System is indicated for the following: 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 (190 words)

The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the AMI Anterior Vertebral Body Staples. The Range 4.5mm Small Stature Rod System is indicated for the following:

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-S1I 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, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Indications for use as stated in the FDA summary.

Also cleared against K042635

8 other devices cite the same predicate.

  • K140765Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  • K122332Towerlox Pedicle Screw SystemCaptiva Spine · 2012
  • K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
  • K112037Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
  • K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010
  • K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009

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/K120099 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120099: 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/K120099

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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