510(k) Report

510(k) · Cleared

Cleared

Mesa Spinal System

K052398510(k) TraditionalCleared Dec 7, 200598-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, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Dec 7, 2005 after a 98-day review. The FDA summary names its predicate without a number. 114 later devices descend from it.

Decided
Dec 7, 2005
Review
98 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

114 later devices descend from it, 17 citing it directly.

Descendants, by year cleared 2018: 10 descendants cleared2012: 6 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2020: 8 descendants cleared2011: 2 descendants cleared2014: 6 descendants cleared2021: 3 descendants cleared2013: 8 descendants cleared2010: 1 descendant cleared2016: 5 descendants cleared2022: 4 descendants cleared2015: 9 descendants cleared2024: 13 descendants cleared2017: 7 descendants cleared2025: 6 descendants cleared2019: 2 descendants cleared2023: 12 descendants cleared2026: 10 descendants cleared20052010201520202025
  1. This deviceK052398 Mesa Spinal SystemK2m, LLC · 2005
  2. Descendant · cites it directly · 65 of its ownK112037 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
  3. Descendant · cites it directly · 65 of its ownK072914 Natural Bridge LP Transverse ConnectorsK2m, Inc. · 2008
  4. Descendant · cites it directly · 53 of its ownK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  5. Descendant · cites it directly · 49 of its ownK112920 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
  6. Descendant · 2 generations on · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012

Showing 5 of 114 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12011: 22012: 62013: 82014: 62015: 92016: 52017: 72018: 102019: 22020: 82021: 32022: 42023: 122024: 132025: 62026: 10
2008high 13 (2024) · low 1 (2008)2026

Most influential descendants

Showing 5 of 114 · See all
  • K112037Range Spinal System (Mesa and Denali)K2m, Inc. · 2011 · cites it directly65descendants
  • K072914Natural Bridge LP Transverse ConnectorsK2m, Inc. · 2008 · cites it directly65descendants
  • K120099Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · cites it directly53descendants
  • K112920Range Spinal System (Mesa and Denali)K2m, Inc. · 2011 · cites it directly49descendants
  • K120656Everest Spinal SystemK2m, Inc. · 2012 · 2 generations on43descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052398Mesa Spinal SystemK2m, LLC2005—
+1K112037Range Spinal System (Mesa and Denali)K2m, Inc.2011—
+1K072914Natural Bridge LP Transverse ConnectorsK2m, Inc.2008—
+1K120099Range Spinal System (Mesa and Denali)K2m, Inc.2012—
+1K112920Range Spinal System (Mesa and Denali)K2m, Inc.2011—
+2K120656Everest Spinal SystemK2m, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201120
201260
201380
201460
201590
201650
201770
2018100
201920
202080
202130
202240
2023120
2024130
202560
2026100
FIG. 1 — Lineage of K052398, 2005–2026Source: 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
Get a 510(k) Report

What was it cleared against? (3)

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
—
*—Versalok Low Back Fixation System
Named without a submission number
—
*—Ovation Polyaxial System
Named without a submission number
—

What descends from it? (114)

See all 114

17 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
K072914Natural Bridge LP Transverse ConnectorsK2m, Inc.200865
K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253
K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149
K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841
K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839
K132361Everest Spinal SystemK2m, Inc.201334
K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415
K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011
K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010

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 MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Mesa 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 Mesa 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 Mesa 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 'pondylolisthesis ( grades 3 and 4 ) of the L5-Sl 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, LLC

8 FDA decisions under this applicant name. See the company

  • K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
  • K140529Everest Spinal SystemK2m, LLC · 2014
  • K052404Denali Deformity SystemK2m, LLC · 2006
  • K060442Pyrenees Cervical Plate SystemK2m, LLC · 2006
  • K051531Tectonic Cervical Plate SystemK2m, LLC · 2005

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/K052398 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052398: Mesa 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/K052398

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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