510(k) Report

510(k) · Cleared

Cleared

Everest Spinal System

K132757510(k) TraditionalCleared Nov 20, 201377-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 Nov 20, 2013 as substantially equivalent to K103440 (K2m, Inc., 2011) and 6 other predicates after a 77-day review. Its family tree reaches back 13 generations to 1985. 41 later devices descend from it.

Decided
Nov 20, 2013
Review
77 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
7

Its longest line of descent runs back 13 generations to K853033 (1985). 252 ancestors in all, the oldest K781443 (1978). 41 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 3 other ancestors2011: 11 other ancestors2009: 8 other ancestors2008: 13 other ancestors2007: 11 other ancestors2010: 8 other ancestors2006: 13 other ancestors2005: 24 other ancestors2000: 15 other ancestors2004: 37 other ancestors2003: 18 other ancestors2002: 17 other ancestors2001: 23 other ancestors1999: 11 other ancestors1998: 10 other ancestors1997: 2 other ancestors1996: 7 other ancestors1978: 1 other ancestor1995: 5 other ancestors1994: 1 other ancestor1984: 1 other ancestor2015: 6 descendants cleared2018: 6 descendants cleared2014: 6 descendants cleared2026: 2 descendants cleared2024: 7 descendants cleared2016: 4 descendants cleared2021: 1 descendant cleared2017: 2 descendants cleared2025: 1 descendant cleared2022: 2 descendants cleared2023: 3 descendants cleared2020: 1 descendant clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001×2: 2 generations cleared close together, K022190 (2002), K030103 (2003) ×2: 2 generations cleared close together, K041203 (2004), K042508 (2004) K080828 · Mountaineer Oct Spinal System · Depuy Spine, Inc. · 2008K110353 · Mountaineer Oct Spinal System · Depuy Spine, Inc. · 2011×2: 2 generations cleared close together, K113654 (2012), K120656 (2012) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 26 other ancestors3 generations back: 54 other ancestors4 generations back: 77 other ancestors5 generations back: 40 other ancestors6 generations back: 21 other ancestors7 generations back: 14 other ancestors8 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 10 descendants3 generations forward: 12 descendants4 generations forward: 8 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant K120656 · Everest Spinal System · K2m, Inc. · 2012K113654 · Caspian · K2m, Inc. · 2012K110353 · Mountaineer Oct Spinal System · Depuy Spine, Inc. · 2011K080828 · Mountaineer Oct Spinal System · Depuy Spine, Inc. · 2008K042508 · Sumit Oct Spinal System and Mountaineer Oct Spinal System · Depuy Spine, Inc. · 2004K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−10−50+5
  1. Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 9 generations between
  3. 3 generations backK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
  4. 2 generations backK113654 CaspianK2m, Inc. · 2012
  5. 1 generation backK120656 Everest Spinal SystemK2m, Inc. · 2012
  6. This deviceK132757 Everest Spinal SystemK2m, Inc. · 2013
  7. Descendant · cites it directly · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
  8. Descendant · cites it directly · 31 of its ownK140529 Everest Spinal SystemK2m, LLC · 2014
  9. Descendant · 2 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  10. Descendant · 2 generations on · 22 of its ownK142360 Everest Spinal SystemK2m, Inc. · 2015
  11. Descendant · 2 generations on · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
Show all 13 generations
  1. Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 5 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
  10. 4 generations backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
  11. 3 generations backK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
  12. 2 generations backK113654 CaspianK2m, Inc. · 2012
  13. 1 generation backK120656 Everest Spinal SystemK2m, Inc. · 2012
  14. This deviceK132757 Everest Spinal SystemK2m, Inc. · 2013

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2014: 62015: 62016: 42017: 22018: 62020: 12021: 12022: 22023: 32024: 72025: 12026: 2
2014high 7 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 41 · See all
  • 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
  • K142360Everest Spinal SystemK2m, Inc. · 2015 · 2 generations on22descendants
  • K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−12K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−11K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−10K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−9K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−8K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−7K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−6K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−5K042508Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc.2004—
−4K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008—
−3K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011—
−2K113654CaspianK2m, Inc.2012—
−1K120656Everest Spinal SystemK2m, Inc.2012—
0 (this device)K132757Everest Spinal SystemK2m, Inc.2013—
+1K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.2014—
+1K140529Everest Spinal SystemK2m, LLC2014—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.2014—
+2K142360Everest Spinal SystemK2m, Inc.2015—
+2K143334Range/Denali/Mesa Spinal SystemK2m, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199410
199550
199670
199720
1998100
1999110
2000150
2001230
2002170
2003180
2004370
2005240
2006130
2007110
2008130
200980
201080
2011110
201230

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201460
201560
201640
201720
201860
202010
202110
202220
202330
202470
202510
202620
FIG. 1 — Lineage of K132757, 1985–2026Source: 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? (7)

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
*K103440Everest Spinal System
Summary page 1
…: KWP, MNI Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K103440, K120656) * K2M Range Spinal System (K070229, K072914, K08061 1, K080792, K121630) 4. IDcscription of the device: T…
K2m, Inc.2011—
*K120656Everest Spinal System
Summary page 1
…KWP, MNI Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K103440, K120656) * K2M Range Spinal System (K070229, K072914, K08061 1, K080792, K121630) 4. IDcscription of the device: The Everes…
K2m, Inc.2012—
*K070229Range Spinal System
Summary page 1
…Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K103440, K120656) * K2M Range Spinal System (K070229, K072914, K08061 1, K080792, K121630) 4. IDcscription of the device: The Everest Spinal System is a top-loading, multip…
K2m, Inc.2007—
*K072914Natural Bridge LP Transverse Connectors
Summary page 1
…3. Predicate or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K103440, K120656) * K2M Range Spinal System (K070229, K072914, K08061 1, K080792, K121630) 4. IDcscription of the device: The Everest Spinal System is a top-loading, multiple compon…
K2m, Inc.2008—
*K080611Mesa Spinal System
Summary page 1
…dicate or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K103440, K120656) * K2M Range Spinal System (K070229, K072914, K08061 1, K080792, K121630) 4. IDcscription of the device: The Everest Spinal System is a top-loading, multiple component, poste…
K2m, Inc.2009—
*K080792K2M Cocr Rod
Summary page 1
…legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K103440, K120656) * K2M Range Spinal System (K070229, K072914, K08061 1, K080792, K121630) 4. IDcscription of the device: The Everest Spinal System is a top-loading, multiple component, posterior (tho…
K2m, Inc.2008—
*K121630Range Spinal System
Summary page 1
…arketed devices which are substantially equivalent * K2M Everest Spinal System (K103440, K120656) * K2M Range Spinal System (K070229, K072914, K08061 1, K080792, K121630) 4. IDcscription of the device: The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-…
K2m, Inc.2012—

Also cleared against K103440: 7 other devices →

What descends from it? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433
K140529Everest Spinal SystemK2m, LLC201431
K151727Everest Spinal SystemK2m, Inc.201511
K173508Everest Spinal SystemK2m20189
K253545Vulcan Spinal SystemK2m, Inc.20260

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 28 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 26 of the 252 ancestors have a recall of any class.
  • Of its descendants, K133944 (K2m, Inc., 2014) has gone furthest, with 33 descendants of its own.
  • 7 other devices also cite its predicate K103440.

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. 2013, 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 may be used in conjunction with the RANGE® (MESAO and DENALI®) Spinal Systems, all of which are cleared for the following indications: 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…

Read the full statement (188 words)

The EVEREST Spinal System may be used in conjunction with the RANGE® (MESAO and DENALI®) Spinal Systems, all of which are cleared for the following indications:

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-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 (DD) (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.

Also cleared against K103440

7 other devices cite the same predicate.

  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K173508Everest Spinal SystemK2m · 2018
  • K171321K2M Navigation InstrumentsK2m · 20171 recall
  • K151216Everest Spinal SystemK2m, Inc. · 2015
  • K140529Everest Spinal SystemK2m, LLC · 2014
  • K133944Range, Spinal System, Everest 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/K132757 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132757: Everest 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/K132757

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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