510(k) · Cleared
ClearedEverest Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 21, 2015 as substantially equivalent to K140529 (K2m, LLC, 2014) and 1 other predicate after a 149-day review. Its family tree reaches back 15 generations to 1985. 22 later devices descend from it.
- Decided
- Jan 21, 2015
- Review
- 149 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K853033 (1985). 257 ancestors in all, the oldest K781443 (1978). 22 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK120656 Everest Spinal SystemK2m, Inc. · 2012
- 2 generations backK132757 Everest Spinal SystemK2m, Inc. · 2013
- 1 generation backK140529 Everest Spinal SystemK2m, LLC · 2014
- This deviceK142360 Everest Spinal SystemK2m, Inc. · 2015
- Descendant · cites it directly · 11 of its ownK151727 Everest Spinal SystemK2m, Inc. · 2015
- Descendant · cites it directly · 11 of its ownK151216 Everest Spinal SystemK2m, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK173508 Everest Spinal SystemK2m · 2018
- Descendant · 2 generations on · 9 of its ownK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- Descendant · 3 generations on · 6 of its ownK181188 EVEREST Spinal SystemK2m, Inc. · 2018
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
- 5 generations backK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
- 4 generations backK113654 CaspianK2m, Inc. · 2012
- 3 generations backK120656 Everest Spinal SystemK2m, Inc. · 2012
- 2 generations backK132757 Everest Spinal SystemK2m, Inc. · 2013
- 1 generation backK140529 Everest Spinal SystemK2m, LLC · 2014
- This deviceK142360 Everest Spinal SystemK2m, Inc. · 2015
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K151727Everest Spinal SystemK2m, Inc. · 2015 · cites it directly11descendants
- K151216Everest Spinal SystemK2m, Inc. · 2015 · cites it directly11descendants
- K173508Everest Spinal SystemK2m · 2018 · cites it directly9descendants
- K161369EVEREST Spinal SystemK2m, Incorporated · 2016 · 2 generations on9descendants
- K181188EVEREST Spinal SystemK2m, Inc. · 2018 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K080828 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2008 | — |
| −5 | K110353 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2011 | — |
| −4 | K113654 | Caspian | K2m, Inc. | 2012 | — |
| −3 | K120656 | Everest Spinal System | K2m, Inc. | 2012 | — |
| −2 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | — |
| −1 | K140529 | Everest Spinal System | K2m, LLC | 2014 | — |
| 0 (this device) | K142360 | Everest Spinal System | K2m, Inc. | 2015 | — |
| +1 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| +1 | K151216 | Everest Spinal System | K2m, Inc. | 2015 | — |
| +1 | K173508 | Everest Spinal System | K2m | 2018 | — |
| +2 | K161369 | EVEREST Spinal System | K2m, Incorporated | 2016 | — |
| +3 | K181188 | EVEREST Spinal System | K2m, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 10 | 0 |
| 1999 | 11 | 0 |
| 2000 | 15 | 0 |
| 2001 | 23 | 0 |
| 2002 | 17 | 0 |
| 2003 | 18 | 0 |
| 2004 | 37 | 0 |
| 2005 | 24 | 0 |
| 2006 | 13 | 0 |
| 2007 | 11 | 0 |
| 2008 | 13 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 0 |
| 2011 | 11 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 7 | 0 |
| 2026 | 1 | 0 |
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 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140529 | Everest Spinal SystemSummary page 4…Orthosis (21 CFR 888.3050) (KWP) 3. Predicate or legally marketed devices which are substantially equivalent : Primary Predicate Everest Spinal System (K140529) Additional Predicates Medtronic CD Horizon (K132328) 4. Description of the device: The Everest Spinal System is… | 2014 |
| * | K132328 | CD Horizon Spinal SystemSummary page 4…cate or legally marketed devices which are substantially equivalent : Primary Predicate Everest Spinal System (K140529) Additional Predicates Medtronic CD Horizon (K132328) 4. Description of the device: The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lum… | 2013 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 months on median.
- 26 of the 257 ancestors have a recall of any class.
- Of its descendants, K151727 (K2m, Inc., 2015) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K140529.
How does its category compare?
All NKB devicesNKB 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
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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.
https://510kreport.com/device/K142360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142360: 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/K142360
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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