510(k) Report

510(k) · Cleared

Cleared

Everest Spinal System

K151216510(k) TraditionalCleared Aug 10, 201596-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 Aug 10, 2015 as substantially equivalent to K142360 (K2m, Inc., 2015) and 3 other predicates after a 96-day review. Its family tree reaches back 17 generations to 2004. 11 later devices descend from it.

Decided
Aug 10, 2015
Review
96 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
4

Its longest line of descent runs back 17 generations to K040583 (2004). 323 ancestors in all, the oldest K781443 (1978). 11 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2014: 2 other ancestors2011: 13 other ancestors2013: 3 other ancestors2012: 7 other ancestors2010: 12 other ancestors2009: 12 other ancestors2008: 18 other ancestors2007: 15 other ancestors2006: 20 other ancestors2005: 29 other ancestors2004: 36 other ancestors2003: 22 other ancestors2001: 28 other ancestors2000: 18 other ancestors1999: 13 other ancestors1998: 12 other ancestors1996: 8 other ancestors2002: 20 other ancestors1997: 5 other ancestors1995: 7 other ancestors1978: 1 other ancestor1993: 1 other ancestor1984: 1 other ancestor1994: 1 other ancestor1985: 1 other ancestor2018: 3 descendants cleared2016: 1 descendant cleared2024: 5 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×3: 3 generations cleared close together, K131321 (2013), K132471 (2013), K140276 (2014) K142381 · Xia 3 Spinal System · Stryker Corp. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 47 other ancestors4 generations back: 69 other ancestors5 generations back: 55 other ancestors6 generations back: 50 other ancestors7 generations back: 52 other ancestors8 generations back: 17 other ancestors9 generations back: 5 other ancestors10 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants K142381 · Xia 3 Spinal System · Stryker Corp. · 2014K140276 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2014K132471 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50+5
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations between
  3. 3 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  4. 2 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  5. 1 generation backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  6. This deviceK151216 Everest Spinal SystemK2m, Inc. · 2015
  7. Descendant · cites it directly · 9 of its ownK173508 Everest Spinal SystemK2m · 2018
  8. Descendant · 2 generations on · 5 of its ownK181119 Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018
  9. Descendant · 3 generations on · 4 of its ownK232341 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023
  10. Descendant · 4 generations on · 3 of its ownK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
  11. Descendant · 5 generations on · 2 of its ownK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
Show all 17 generations
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 5 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 4 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 3 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 2 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 1 generation backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. This deviceK151216 Everest Spinal SystemK2m, Inc. · 2015

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2016: 12018: 32023: 12024: 52026: 1
2016high 5 (2024) · low 0 (2017)2026

Most influential descendants

Showing 5 of 11 · See all
  • K173508Everest Spinal SystemK2m · 2018 · cites it directly9descendants
  • K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018 · 2 generations on5descendants
  • K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023 · 3 generations on4descendants
  • K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024 · 4 generations on3descendants
  • K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd. · 2024 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−15K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−14K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−12K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−11K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−10K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−9K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−8K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−7K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−6K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−5K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−1K142381Xia 3 Spinal SystemStryker Corp.2014—
0 (this device)K151216Everest Spinal SystemK2m, Inc.2015—
+1K173508Everest Spinal SystemK2m2018—
+2K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.2018—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.2023—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.2024—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated…CarboFix Orthopedics, Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199310
199410
199570
199680
199750
1998120
1999130
2000180
2001280
2002200
2003220
2004360
2005290
2006200
2007150
2008180
2009120
2010120
2011130
201270
201330
201420
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201830
202310
202450
202610
FIG. 1 — Lineage of K151216, 2004–2026Source: 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? (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
*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 (K103440)  Medtronic CD Horizon (K140449)  Stryker Xia (K142381) D…
K2m, Inc.2015—
*K103440Everest Spinal System
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 (K103440)  Medtronic CD Horizon (K140449)  Stryker Xia (K142381) Device Description The Everest Spinal System is a top-loading…
K2m, Inc.2011—
*K140449CD Horizon Spinal System
Summary page 4
…Code KWP) Predicate Device(s) Primary Predicate Everest Spinal System (K142360) Additional Predicates  Everest Spinal System (K103440)  Medtronic CD Horizon (K140449)  Stryker Xia (K142381) Device Description The Everest Spinal System is a top-loading, multiple component, posterior (thor…
Medtronic Sofamor Danek, Inc.2014—
*K142381Xia 3 Spinal System
Summary page 4
…(s) Primary Predicate Everest Spinal System (K142360) Additional Predicates  Everest Spinal System (K103440)  Medtronic CD Horizon (K140449)  Stryker Xia (K142381) Device Description The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation…
Stryker Corp.2014—

Also cleared against K142360: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K173508Everest Spinal SystemK2m20189
K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160

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 11 years and passes through 6 companies; a new generation was cleared every 5 months on median.
  • 37 of the 323 ancestors have a recall of any class.
  • Of its descendants, K173508 (K2m, 2018) 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 as stated in the FDA summary.

Also cleared against K142360

2 other devices cite the same predicate.

  • K173508Everest Spinal SystemK2m · 2018
  • K151727Everest 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/K151216 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151216: 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/K151216

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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