510(k) Report

510(k) · Cleared

Cleared

Everest Spinal System

K151727510(k) TraditionalCleared Sep 17, 201583-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. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Sep 17, 2015 as substantially equivalent to K142360 (K2m, Inc., 2015) and 5 other predicates after an 83-day review. Its family tree reaches back 20 generations to 1985. 11 later devices descend from it.

Decided
Sep 17, 2015
Review
83 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
6

Its longest line of descent runs back 20 generations to K853033 (1985). 348 ancestors in all, the oldest K781443 (1978). 11 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 2 other ancestors2013: 8 other ancestors2008: 18 other ancestors2014: 1 other ancestor2012: 9 other ancestors2011: 16 other ancestors2009: 14 other ancestors2007: 15 other ancestors2005: 30 other ancestors2003: 20 other ancestors2002: 18 other ancestors1999: 12 other ancestors2010: 12 other ancestors2006: 18 other ancestors2004: 42 other ancestors2000: 18 other ancestors1998: 13 other ancestors1997: 4 other ancestors1996: 8 other ancestors1994: 2 other ancestors2001: 28 other ancestors1995: 7 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 3 other ancestors1978: 1 other ancestor1984: 1 other ancestor2024: 3 descendants cleared2016: 1 descendant cleared2021: 1 descendant cleared2018: 2 descendants cleared2017: 1 descendant cleared2026: 1 descendant cleared2020: 1 descendant cleared2023: 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) K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004×3: 3 generations cleared close together, K062174 (2006), K063156 (2006), K063741 (2007) K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K111571 · Viper Systems · Johnson & Johnson · 2011K121016 · Range Spinal System (Mesa and Denali) · K2m, Inc. · 2012×2: 2 generations cleared close together, K130330 (2013), K131784 (2013) ×4: 4 generations cleared close together, K133944 (2014), K141873 (2014), K143334 (2015), K150325 (2015) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 21 other ancestors3 generations back: 66 other ancestors4 generations back: 89 other ancestors5 generations back: 66 other ancestors6 generations back: 38 other ancestors7 generations back: 20 other ancestors8 generations back: 13 other ancestors9 generations back: 3 other ancestors10 generations back: 4 other ancestors11 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K150325 · Range/Denali/Mesa Spinal System · K2m, Inc. · 2015K143334 · Range/Denali/Mesa Spinal System · K2m, Inc. · 2015K141873 · Range/Mesa/Denali Spinal System · K2m, Inc. · 2014K133944 · Range, Spinal System, Everest Spinal System · K2m, Inc. · 2014K131784 · Range Spinal System · K2m, Inc. · 2013K130330 · Range Spinal System · K2m, Inc. · 2013K121016 · Range Spinal System (Mesa and Denali) · K2m, Inc. · 2012K111571 · Viper Systems · Johnson & Johnson · 2011K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K063741 · Expedium Spine System · Depuy Spine, Inc. · 2007K063156 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · 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. · 1985−20−15−10−50+5
  1. Root · 20 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 16 generations between
  3. 3 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  4. 2 generations backK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
  5. 1 generation backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
  6. This deviceK151727 Everest Spinal SystemK2m, Inc. · 2015
  7. Descendant · cites it directly · 9 of its ownK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
  8. Descendant · 2 generations on · 6 of its ownK181188 EVEREST Spinal SystemK2m, Inc. · 2018
  9. Descendant · 3 generations on · 5 of its ownK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
  10. Descendant · 4 generations on · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
  11. Descendant · cites it directly · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
Show all 20 generations
  1. Root · 20 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 19 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 18 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 17 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 16 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 15 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 14 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 13 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 12 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 11 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 10 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 9 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 8 generations backK111571 Viper SystemsJohnson & Johnson · 2011
  14. 7 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  15. 6 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
  16. 5 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
  17. 4 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
  18. 3 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  19. 2 generations backK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
  20. 1 generation backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
  21. This deviceK151727 Everest Spinal SystemK2m, Inc. · 2015

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12018: 22020: 12021: 12023: 12024: 32026: 1
2016high 3 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 11 · See all
  • K161369EVEREST Spinal SystemK2m, Incorporated · 2016 · cites it directly9descendants
  • K181188EVEREST Spinal SystemK2m, Inc. · 2018 · 2 generations on6descendants
  • K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc. · 2018 · 3 generations on5descendants
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · 4 generations on4descendants
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−19K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−18K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−17K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−16K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−15K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−14K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−13K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−12K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−11K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−10K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−9K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−8K111571Viper SystemsJohnson & Johnson2011—
−7K121016Range Spinal System (Mesa and Denali)K2m, Inc.2012—
−6K130330Range Spinal SystemK2m, Inc.2013—
−5K131784Range Spinal SystemK2m, Inc.2013—
−4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.2014—
−3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.2014—
−2K143334Range/Denali/Mesa Spinal SystemK2m, Inc.2015—
−1K150325Range/Denali/Mesa Spinal SystemK2m, Inc.2015—
0 (this device)K151727Everest Spinal SystemK2m, Inc.2015—
+1K161369EVEREST Spinal SystemK2m, Incorporated2016—
+2K181188EVEREST Spinal SystemK2m, Inc.2018—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT…K2m, Inc.2018—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System…Stryker Spine2023—
+1K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal…Stryker Spine2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199030
199250
199330
199420
199570
199680
199740
1998130
1999120
2000180
2001280
2002180
2003200
2004420
2005300
2006180
2007150
2008180
2009140
2010120
2011160
201290
201380
201410
201520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
201820
202010
202110
202310
202430
202610
FIG. 1 — Lineage of K151727, 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? (6)

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
*K142360Everest Spinal System
Summary page 4
…CFR 888.3060, Product Code KWQ) Spinal Interlaminal fixation Orthosis (21 CFR 888.3050, Product Code KWP) Predicate Device(s) Primary Predicate Everest Spinal System (K142360) Additional Predicates  Everest Spinal System (K081107, K132757)  Range/Denali/Mesa (K150325)  Z-Medical (K143200)…
K2m, Inc.2015—
*K081107Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors
Summary page 4
…n Orthosis (21 CFR 888.3050, Product Code KWP) Predicate Device(s) Primary Predicate Everest Spinal System (K142360) Additional Predicates  Everest Spinal System (K081107, K132757)  Range/Denali/Mesa (K150325)  Z-Medical (K143200)  Ulrich (K123717) Device Description The Everest Spi…
K2m, Inc.2008—
*K132757Everest Spinal System
Summary page 4
…s (21 CFR 888.3050, Product Code KWP) Predicate Device(s) Primary Predicate Everest Spinal System (K142360) Additional Predicates  Everest Spinal System (K081107, K132757)  Range/Denali/Mesa (K150325)  Z-Medical (K143200)  Ulrich (K123717) Device Description The Everest Spinal Syste…
K2m, Inc.2013—
*K150325Range/Denali/Mesa Spinal System
Summary page 4
…WP) Predicate Device(s) Primary Predicate Everest Spinal System (K142360) Additional Predicates  Everest Spinal System (K081107, K132757)  Range/Denali/Mesa (K150325)  Z-Medical (K143200)  Ulrich (K123717) Device Description The Everest Spinal System is a top-loading, multiple compo…
K2m, Inc.2015—
*K143200MIS Z-Pedicle Screw System
Summary page 4
…Primary Predicate Everest Spinal System (K142360) Additional Predicates  Everest Spinal System (K081107, K132757)  Range/Denali/Mesa (K150325)  Z-Medical (K143200)  Ulrich (K123717) Device Description The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-…
Z-Medical GmbH & Co. KG2015—
*K123717Ucentum
Summary page 4
…st Spinal System (K142360) Additional Predicates  Everest Spinal System (K081107, K132757)  Range/Denali/Mesa (K150325)  Z-Medical (K143200)  Ulrich (K123717) Device Description The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation…
Ulrich GmbH & Co. KG20131

Also cleared against K142360: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K161369EVEREST Spinal SystemK2m, Incorporated20169
K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241
K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210

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 30 years and passes through 7 companies; a new generation was cleared every 10 months on median.
  • 33 of the 348 ancestors have a recall of any class.
  • Of its descendants, K161369 (K2m, Incorporated, 2016) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K142360.

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. 2015, 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: Posterior 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)…

Read the full statement (154 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:

Posterior 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K142360

2 other devices cite the same predicate.

  • K173508Everest Spinal SystemK2m · 2018
  • K151216Everest Spinal SystemK2m, Inc. · 2015

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 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/K151727 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151727: 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/K151727

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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