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. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 3, 2013 as substantially equivalent to K103440 (K2m, Inc., 2011) and 9 other predicates after a 65-day review. Its family tree reaches back 15 generations to 1985. 34 later devices descend from it.
- Decided
- Oct 3, 2013
- Review
- 65 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 15 generations to K853033 (1985). 295 ancestors in all, the oldest K781443 (1978). 34 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 1 generation backK130330 Range Spinal SystemK2m, Inc. · 2013
- This deviceK132361 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · cites it directly · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- Descendant · 3 generations on · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- Descendant · 3 generations on · 13 of its ownK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
- Descendant · 4 generations on · 12 of its ownK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
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 backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 1 generation backK130330 Range Spinal SystemK2m, Inc. · 2013
- This deviceK132361 Everest Spinal SystemK2m, Inc. · 2013
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · cites it directly33descendants
- K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · 2 generations on30descendants
- K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 3 generations on16descendants
- K171832Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017 · 3 generations on13descendants
- K150325Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 4 generations on12descendants
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 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −2 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −1 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| 0 (this device) | K132361 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +1 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +2 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| +3 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| +3 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | — |
| +4 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 18 | 0 |
| 2001 | 27 | 0 |
| 2002 | 17 | 0 |
| 2003 | 20 | 0 |
| 2004 | 39 | 0 |
| 2005 | 29 | 0 |
| 2006 | 17 | 0 |
| 2007 | 14 | 0 |
| 2008 | 17 | 0 |
| 2009 | 12 | 0 |
| 2010 | 9 | 0 |
| 2011 | 13 | 0 |
| 2012 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2026 | 2 | 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 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
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K103440 | Everest Spinal SystemSummary page 1…de: KWP. M/NI Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: 0 K2M Everest Spinal System (K 103440, K120656) 0 K2M Range Spinal System (K052398, K070229, K080792, K08 1381, KI 12037, KI 30330) a NuVasive SpherX (K… | 2011 |
| * | K120656 | Everest Spinal SystemSummary page 1…KWP. M/NI Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: 0 K2M Everest Spinal System (K 103440, K120656) 0 K2M Range Spinal System (K052398, K070229, K080792, K08 1381, KI 12037, KI 30330) a NuVasive SpherX (K092287)… | 2012 |
| * | K052398 | Mesa Spinal SystemSummary page 1…lass 11 3. Predicate or legally marketed devices which are substantially equivalent: 0 K2M Everest Spinal System (K 103440, K120656) 0 K2M Range Spinal System (K052398, K070229, K080792, K08 1381, KI 12037, KI 30330) a NuVasive SpherX (K092287) * Globus Resolve (K083416) 4. Descr… | 2005 |
| * | K070229 | Range Spinal SystemSummary page 1…3. Predicate or legally marketed devices which are substantially equivalent: 0 K2M Everest Spinal System (K 103440, K120656) 0 K2M Range Spinal System (K052398, K070229, K080792, K08 1381, KI 12037, KI 30330) a NuVasive SpherX (K092287) * Globus Resolve (K083416) 4. Description of… | 2007 |
| * | K080792 | K2M Cocr RodSummary page 1…cate or legally marketed devices which are substantially equivalent: 0 K2M Everest Spinal System (K 103440, K120656) 0 K2M Range Spinal System (K052398, K070229, K080792, K08 1381, KI 12037, KI 30330) a NuVasive SpherX (K092287) * Globus Resolve (K083416) 4. Description of the devi… | 2008 |
| * | K081381 | Range Spinal System, Large Denali ScrewsSummary page 1…egally marketed devices which are substantially equivalent: 0 K2M Everest Spinal System (K 103440, K120656) 0 K2M Range Spinal System (K052398, K070229, K080792, K08 1381, KI 12037, KI 30330) a NuVasive SpherX (K092287) * Globus Resolve (K083416) 4. Description of the device:… | 2008 |
| * | K112037 | Range Spinal System (Mesa and Denali) | 2011 |
| * | K130330 | Range Spinal System | 2013 |
| * | K092287 | Nuvasive Spherx II - Pedicle Screw SystemSummary page 1…0 K2M Everest Spinal System (K 103440, K120656) 0 K2M Range Spinal System (K052398, K070229, K080792, K08 1381, KI 12037, KI 30330) a NuVasive SpherX (K092287) * Globus Resolve (K083416) 4. Description of the device: The Everest Spinal System is a top-loading, multiple compo… | 2009 |
| * | K083416 | Revolve Stabilization SystemSummary page 1…(K 103440, K120656) 0 K2M Range Spinal System (K052398, K070229, K080792, K08 1381, KI 12037, KI 30330) a NuVasive SpherX (K092287) * Globus Resolve (K083416) 4. Description of the device: The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-… | 2009 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133944 | Range, Spinal System, Everest Spinal System | 2014 | 33 |
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 7 companies; a new generation was cleared every 12 months on median.
- 27 of the 295 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 devicesMNI 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EVEREST Spinal System may be used in conjunction with the RANGlE (MESA" 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; pseudoarthbrosis; and failed previous fusion. It…
Read the full statement (190 words)
The EVEREST Spinal System may be used in conjunction with the RANGlE (MESA" 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; pseudoarthbrosis; 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 (DDD ) (defined as back pain of discagenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; traumna ( 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.
https://510kreport.com/device/K132361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132361: 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/K132361
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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