510(k) Report

510(k) · Cleared

Cleared

K2M Cocr Rod

K080792510(k) SpecialCleared Apr 8, 200819-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 Apr 8, 2008 as substantially equivalent to K070229 (K2m, Inc., 2007) after a 19-day review. Its family tree reaches back 1 generation to 2007. 1 of the 598 devices in its family, counting itself, has a Class I recall. 596 later devices descend from it.

Decided
Apr 8, 2008
Review
19 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K070229 (2007). 596 later devices descend from it, 18 citing it directly. 1 of the 598 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2010: 9 descendants cleared2012: 25 descendants cleared2009: 7 descendants cleared2013: 31 descendants cleared2011: 9 descendants cleared2014: 22 descendants cleared2008: 1 descendant cleared2016: 27 descendants cleared2022: 36 descendants cleared2015: 32 descendants cleared2019: 40 descendants cleared2017: 42 descendants cleared2018: 40 descendants cleared2026: 49 descendants cleared2024: 55 descendants cleared2021: 28 descendants cleared, 1 with a Class I recall12023: 57 descendants cleared2020: 37 descendants cleared2025: 49 descendants clearedK070229 · Range Spinal System · K2m, Inc. · 200720052010201520202025
Descendants, by generation 1 generation forward: 18 descendants2 generations forward: 49 descendants3 generations forward: 83 descendants4 generations forward: 108 descendants5 generations forward: 132 descendants6 generations forward: 95 descendants, 1 with a Class I recall17 generations forward: 51 descendants8 generations forward: 27 descendants9 generations forward: 17 descendants10 generations forward: 13 descendants11 generations forward: 3 descendants K070229 · Range Spinal System · K2m, Inc. · 20070+5+10
  1. Root · 1 generation backK070229 Range Spinal SystemK2m, Inc. · 2007
  2. This deviceK080792 K2M Cocr RodK2m, Inc. · 2008
  3. Descendant · cites it directly · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
  4. Descendant · cites it directly · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
  5. Descendant · 2 generations on · 337 of its ownK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
  6. Descendant · 2 generations on · 263 of its ownK092473 Expedium Spine SystemDepuy Spine, Inc. · 2009
  7. Descendant · 2 generations on · 260 of its ownK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled

Showing 5 of 596 descendants. See all descendants

Descendants cleared per year

2008: 12009: 72010: 92011: 92012: 252013: 312014: 222015: 322016: 272017: 422018: 402019: 402020: 372021: 282022: 362023: 572024: 552025: 492026: 49
2008high 57 (2023) · low 1 (2008)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 596 · See all
  • K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · cites it directly518descendants
  • K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly462descendants
  • K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · 2 generations on337descendants
  • K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · 2 generations on263descendants
  • K101070Expedium Spine SystemMedos International SARL · 2010 · 2 generations on260descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K070229Range Spinal SystemK2m, Inc.2007—
0 (this device)K080792K2M Cocr RodK2m, Inc.2008—
+1K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009—
+2K090648Viper 2 SystemDepuy Spine, Inc.2009—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009—
+2K101070Expedium Spine SystemMedos International SARL20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200970
201090
201190
2012250
2013310
2014220
2015320
2016270
2017420
2018400
2019400
2020370
2021281
2022360
2023570
2024550
2025490
2026490
FIG. 1 — Lineage of K080792, 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? (4)

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 4
…=== Indications for Use 510(k) Number: Device Name: Range Spinal System Indications for Use: The Range Spinal System (K070229) is cleared for the following indications: Non-cervical spinal fixation devices intended for posterior, non-pedicle fixation for…
K2m, Inc.2007—
*—Xia Spinal System
Named without a submission number
—
*—Quantum Spinal System
Named without a submission number
—
*—CD Horizon Spinal System
Named without a submission number
—

Also cleared against K070229: 23 other devices →

What descends from it? (596)

See all 596

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

NumberDeviceApplicantDecidedDescendants
K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518
K090230Expedium Spine SystemDepuy Spine, Inc.2009462
K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177
K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.2009130
K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165
K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253
K120656Everest Spinal SystemK2m, Inc.201243
K132757Everest Spinal SystemK2m, Inc.201341
K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K082942 (Depuy Spine, Inc., 2008) has gone furthest, with 518 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. 2008, 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 (K070229) is cleared for the following indications: 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…

Read the full statement (155 words)

The Range Spinal System (K070229) is cleared for the following indications:

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.

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/K080792 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080792: K2M Cocr Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080792

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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