510(k) Report

510(k) · Cleared

Cleared

Everest Spinal System

K140529510(k) SpecialCleared May 22, 201479-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 · NKB Thoracolumbosacral Pedicle Screw System

Cleared on May 22, 2014 as substantially equivalent to K103440 (K2m, Inc., 2011) and 12 other predicates after a 79-day review. Its family tree reaches back 14 generations to 1985. 31 later devices descend from it.

Decided
May 22, 2014
Review
79 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
13

Its longest line of descent runs back 14 generations to K853033 (1985). 256 ancestors in all, the oldest K781443 (1978). 31 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2011: 11 other ancestors2010: 9 other ancestors2009: 8 other ancestors2008: 13 other ancestors2007: 11 other ancestors1996: 8 other ancestors2012: 3 other ancestors2006: 13 other ancestors2005: 24 other ancestors2004: 37 other ancestors1999: 11 other ancestors2003: 18 other ancestors2002: 17 other ancestors2001: 23 other ancestors2000: 15 other ancestors1995: 5 other ancestors1998: 10 other ancestors1997: 2 other ancestors1978: 1 other ancestor1994: 1 other ancestor1984: 1 other ancestor2018: 5 descendants cleared2015: 6 descendants cleared2014: 1 descendant cleared2024: 7 descendants cleared2017: 2 descendants cleared2025: 1 descendant cleared2022: 1 descendant cleared2016: 2 descendants cleared2021: 1 descendant cleared2023: 3 descendants cleared2026: 1 descendant 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) K132757 · Everest Spinal System · K2m, Inc. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 20 other ancestors3 generations back: 50 other ancestors4 generations back: 71 other ancestors5 generations back: 63 other ancestors6 generations back: 16 other ancestors7 generations back: 10 other ancestors8 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K132757 · Everest Spinal System · K2m, Inc. · 2013K120656 · 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 · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 10 generations between
  3. 3 generations backK113654 CaspianK2m, Inc. · 2012
  4. 2 generations backK120656 Everest Spinal SystemK2m, Inc. · 2012
  5. 1 generation backK132757 Everest Spinal SystemK2m, Inc. · 2013
  6. This deviceK140529 Everest Spinal SystemK2m, LLC · 2014
  7. Descendant · cites it directly · 22 of its ownK142360 Everest Spinal SystemK2m, Inc. · 2015
  8. Descendant · cites it directly · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
  9. Descendant · cites it directly · 15 of its ownK140765 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  10. Descendant · 2 generations on · 13 of its ownK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
  11. Descendant · 2 generations on · 12 of its ownK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
Show all 14 generations
  1. Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 6 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
  10. 5 generations backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
  11. 4 generations backK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
  12. 3 generations backK113654 CaspianK2m, Inc. · 2012
  13. 2 generations backK120656 Everest Spinal SystemK2m, Inc. · 2012
  14. 1 generation backK132757 Everest Spinal SystemK2m, Inc. · 2013
  15. This deviceK140529 Everest Spinal SystemK2m, LLC · 2014

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2014: 12015: 62016: 22017: 22018: 52020: 12021: 12022: 12023: 32024: 72025: 12026: 1
2014high 7 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 31 · See all
  • K142360Everest Spinal SystemK2m, Inc. · 2015 · cites it directly22descendants
  • K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · cites it directly16descendants
  • K140765Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · cites it directly15descendants
  • K171832Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017 · 2 generations on13descendants
  • K150325Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 2 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−13K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−12K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−11K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−10K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−9K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−8K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−7K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−6K042508Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc.2004—
−5K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008—
−4K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011—
−3K113654CaspianK2m, Inc.2012—
−2K120656Everest Spinal SystemK2m, Inc.2012—
−1K132757Everest Spinal SystemK2m, Inc.2013—
0 (this device)K140529Everest Spinal SystemK2m, LLC2014—
+1K142360Everest Spinal SystemK2m, Inc.2015—
+1K143334Range/Denali/Mesa Spinal SystemK2m, Inc.2015—
+1K140765Range/Mesa/Denali Spinal SystemK2m, Inc.2014—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.2017—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199410
199550
199680
199720
1998100
1999110
2000150
2001230
2002170
2003180
2004370
2005240
2006130
2007110
2008130
200980
201090
2011110
201230
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201560
201620
201720
201850
202010
202110
202210
202330
202470
202510
202610
FIG. 1 — Lineage of K140529, 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (13)

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
…, MNH. KWQ. OSI-, Regulatory Class: Class III 3. Predicate or legally marketed devices which are substantially equivalent: " K2M Everest Spinal System (K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) *…
K2m, Inc.2011—
*K120656Everest Spinal System
Summary page 1
…Q. OSI-, Regulatory Class: Class III 3. Predicate or legally marketed devices which are substantially equivalent: " K2M Everest Spinal System (K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic…
K2m, Inc.2012—
*K132757Everest Spinal System
Summary page 1
…Regulatory Class: Class III 3. Predicate or legally marketed devices which are substantially equivalent: " K2M Everest Spinal System (K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic CD Horiz…
K2m, Inc.2013—
*K070229Range Spinal System
Summary page 1
…3. Predicate or legally marketed devices which are substantially equivalent: " K2M Everest Spinal System (K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic CD Horizon (K961633, K090390, K132328) 4. Descr…
K2m, Inc.2007—
*K072914Natural Bridge LP Transverse Connectors
Summary page 1
…icate or legally marketed devices which are substantially equivalent: " K2M Everest Spinal System (K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic CD Horizon (K961633, K090390, K132328) 4. Description of…
K2m, Inc.2008—
*K080792K2M Cocr Rod
Summary page 1
…legally marketed devices which are substantially equivalent: " K2M Everest Spinal System (K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic CD Horizon (K961633, K090390, K132328) 4. Description of the devi…
K2m, Inc.2008—
*K081381Range Spinal System, Large Denali Screws
Summary page 1
…arketed devices which are substantially equivalent: " K2M Everest Spinal System (K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic CD Horizon (K961633, K090390, K132328) 4. Description of the device:…
K2m, Inc.2008—
*K100851Range Spinal System
Summary page 1
…evices which are substantially equivalent: " K2M Everest Spinal System (K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic CD Horizon (K961633, K090390, K132328) 4. Description of the device: The Eve…
K2m, Inc.2010—
*K112037Range Spinal System (Mesa and Denali)K2m, Inc.2011—
*K112920Range Spinal System (Mesa and Denali)K2m, Inc.2011—
*K961633CD Horizon Spinal System
Summary page 1
…al System (K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic CD Horizon (K961633, K090390, K132328) 4. Description of the device: The Everest Spinal System is a top-loading, multiple component, posterio…
Sofamor Danek USA,Inc.1996—
*K090390CD Horizon Spinal System
Summary page 1
…(K103440. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic CD Horizon (K961633, K090390, K132328) 4. Description of the device: The Everest Spinal System is a top-loading, multiple component, posterior (thorac…
Medtronic Sofamor Danek2009—
*K132328CD Horizon Spinal System
Summary page 1
…. K120656, K132757) " K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, Ki 12037, KI 12920) * Medtronic CD Horizon (K961633, K090390, K132328) 4. Description of the device: The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-…
Medtronic Sofamor Danek USA, Inc.2013—

Also cleared against K103440: 7 other devices →

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K142360Everest Spinal SystemK2m, Inc.201522
K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516
K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415
K173508Everest Spinal SystemK2m20189

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 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
  • 26 of the 256 ancestors have a recall of any class.
  • Of its descendants, K142360 (K2m, Inc., 2015) has gone furthest, with 22 descendants of its own.
  • 7 other devices also cite its predicate K103440.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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…

Read the full statement (153 words)

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

Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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
  • K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
  • K132757Everest Spinal SystemK2m, Inc. · 2013

More from K2m, LLC

8 FDA decisions under this applicant name. See the company

  • K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
  • K052404Denali Deformity SystemK2m, LLC · 2006
  • K060442Pyrenees Cervical Plate SystemK2m, LLC · 2006
  • K052398Mesa Spinal SystemK2m, LLC · 2005
  • K051531Tectonic Cervical Plate SystemK2m, LLC · 2005

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K140529 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140529: 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/K140529

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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