510(k) Report

510(k) · Cleared

Cleared

Range Spinal System

K070229510(k) TraditionalCleared May 3, 200799-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 3, 2007 after a 99-day review. The FDA summary names its predicate without a number. 1 of the 599 devices in its family, counting itself, has a Class I recall. 598 later devices descend from it.

Decided
May 3, 2007
Review
99 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

598 later devices descend from it, 24 citing it directly. 1 of the 599 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2013: 31 descendants cleared2010: 9 descendants cleared2012: 25 descendants cleared2008: 2 descendants cleared2024: 55 descendants cleared2015: 32 descendants cleared2017: 42 descendants cleared2014: 22 descendants cleared2011: 10 descendants cleared2016: 27 descendants cleared2009: 7 descendants cleared2018: 40 descendants cleared2026: 49 descendants cleared2025: 49 descendants cleared2020: 37 descendants cleared2022: 36 descendants cleared2019: 40 descendants cleared2023: 57 descendants cleared2021: 28 descendants cleared, 1 with a Class I recall120052010201520202025
  1. This deviceK070229 Range Spinal SystemK2m, Inc. · 2007
  2. Descendant · cites it directly · 596 of its ownK080792 K2M Cocr RodK2m, Inc. · 2008
  3. Descendant · 2 generations on · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
  4. Descendant · 2 generations on · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
  5. Descendant · 3 generations on · 337 of its ownK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
  6. Descendant · 3 generations on · 263 of its ownK092473 Expedium Spine SystemDepuy Spine, Inc. · 2009

Showing 5 of 598 descendants. See all descendants

Descendants cleared per year

2008: 22009: 72010: 92011: 102012: 252013: 312014: 222015: 322016: 272017: 422018: 402019: 402020: 372021: 282022: 362023: 572024: 552025: 492026: 49
2008high 57 (2023) · low 2 (2008)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 598 · See all
  • K080792K2M Cocr RodK2m, Inc. · 2008 · cites it directly596descendants
  • K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 2 generations on518descendants
  • K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · 2 generations on462descendants
  • K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · 3 generations on337descendants
  • K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · 3 generations on263descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070229Range Spinal SystemK2m, Inc.2007—
+1K080792K2M Cocr RodK2m, Inc.2008—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008—
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009—
+3K090648Viper 2 SystemDepuy Spine, Inc.2009—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200970
201090
2011100
2012250
2013310
2014220
2015320
2016270
2017420
2018400
2019400
2020370
2021281
2022360
2023570
2024550
2025490
2026490
FIG. 1 — Lineage of K070229, 2007–2026Source: 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.

1 device in this family has a Class I recall. 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? (2)

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
*—Denali Spine System
Named without a submission number
—
*—Mesa Spinal System
Named without a submission number
—

What descends from it? (598)

See all 598

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

NumberDeviceApplicantDecidedDescendants
K080792K2M Cocr RodK2m, Inc.2008596
K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177
K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165
K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253
K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149
K120656Everest Spinal SystemK2m, Inc.201243
K132757Everest Spinal SystemK2m, Inc.201341
K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238
K130330Range Spinal SystemK2m, Inc.201336
K120899Range Spinal System, Unit RodK2m, Inc.201235

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K080792 (K2m, Inc., 2008) has gone furthest, with 596 descendants of its own.

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. 2007, 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 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 (161 words)

The Range 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 Range 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, Inc.

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https://510kreport.com/device/K070229 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070229: Range Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070229

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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