510(k) Report

510(k) · Cleared

Cleared

Everest Spinal System

K103440510(k) TraditionalCleared Mar 17, 2011114-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 Mar 17, 2011 after a 114-day review. The FDA summary names its predicate without a number. 43 later devices descend from it.

Decided
Mar 17, 2011
Review
114 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

43 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2024: 7 descendants cleared2018: 6 descendants cleared2015: 6 descendants cleared2013: 2 descendants cleared2014: 6 descendants cleared2017: 2 descendants cleared2026: 2 descendants cleared2016: 4 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2022: 2 descendants cleared2021: 1 descendant cleared2023: 3 descendants cleared2010201520202025
  1. This deviceK103440 Everest Spinal SystemK2m, Inc. · 2011
  2. Descendant · cites it directly · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
  3. Descendant · cites it directly · 34 of its ownK132361 Everest Spinal SystemK2m, Inc. · 2013
  4. Descendant · cites it directly · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
  5. Descendant · cites it directly · 31 of its ownK140529 Everest Spinal SystemK2m, LLC · 2014
  6. Descendant · 2 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2013: 22014: 62015: 62016: 42017: 22018: 62020: 12021: 12022: 22023: 32024: 72025: 12026: 2
2013high 7 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 43 · See all
  • K132757Everest Spinal SystemK2m, Inc. · 2013 · cites it directly41descendants
  • K132361Everest Spinal SystemK2m, Inc. · 2013 · cites it directly34descendants
  • K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · cites it directly33descendants
  • K140529Everest Spinal SystemK2m, LLC · 2014 · cites it directly31descendants
  • K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · 2 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K103440Everest Spinal SystemK2m, Inc.2011—
+1K132757Everest Spinal SystemK2m, Inc.2013—
+1K132361Everest Spinal SystemK2m, Inc.2013—
+1K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.2014—
+1K140529Everest Spinal SystemK2m, LLC2014—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201460
201560
201640
201720
201860
202010
202110
202220
202330
202470
202510
202620
FIG. 1 — Lineage of K103440, 2011–2026Source: 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? (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
*—K2M Range Spinal System
Named without a submission number
—
*—K2M Mesa Spinal System
Named without a submission number
—
*—K2M Denali Spinal System
Named without a submission number
—
*—Stryker Xia
Named without a submission number
—

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K132757Everest Spinal SystemK2m, Inc.201341
K132361Everest Spinal SystemK2m, Inc.201334
K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433
K140529Everest Spinal SystemK2m, LLC201431
K151216Everest Spinal SystemK2m, Inc.201511
K173508Everest Spinal SystemK2m20189
K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241
K171321K2M Navigation InstrumentsK2m20171

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, K132757 (K2m, Inc., 2013) has gone furthest, with 41 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. 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 Everest Spinal System is a non-cervical, pedicle screw fixation device 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); tmhnor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S I vertebra in skeletally mature…

Read the full statement (169 words)

The Everest Spinal System is a non-cervical, pedicle screw fixation device 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); tmhnor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S I 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.

Indications for use as stated in the FDA summary.

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

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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/K103440 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103440: Everest Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103440

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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