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 Apr 4, 2012 as substantially equivalent to K081107 (K2m, Inc., 2008) and 12 other predicates after a 30-day review. Its family tree reaches back 12 generations to 1985. 43 later devices descend from it.
- Decided
- Apr 4, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 12 generations to K853033 (1985). 113 ancestors in all, the oldest K841189 (1984). 43 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
- 2 generations backK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
- 1 generation backK113654 CaspianK2m, Inc. · 2012
- This deviceK120656 Everest Spinal SystemK2m, Inc. · 2012
- Descendant · cites it directly · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · cites it directly · 34 of its ownK132361 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · cites it directly · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · cites it directly · 31 of its ownK140529 Everest Spinal SystemK2m, LLC · 2014
- Descendant · 2 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
- 2 generations backK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
- 1 generation backK113654 CaspianK2m, Inc. · 2012
- This deviceK120656 Everest Spinal SystemK2m, Inc. · 2012
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K132757Everest Spinal SystemK2m, Inc. · 2013 · cites it directly41descendants
- K132361Everest Spinal SystemK2m, Inc. · 2013 · cites it directly34descendants
- K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · cites it directly33descendants
- K140529Everest Spinal SystemK2m, LLC · 2014 · cites it directly31descendants
- K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K080828 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2008 | — |
| −2 | K110353 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2011 | — |
| −1 | K113654 | Caspian | K2m, Inc. | 2012 | — |
| 0 (this device) | K120656 | Everest Spinal System | K2m, Inc. | 2012 | — |
| +1 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +1 | K132361 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +1 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +1 | K140529 | Everest Spinal System | K2m, LLC | 2014 | — |
| +2 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 8 | 0 |
| 2000 | 2 | 0 |
| 2001 | 14 | 0 |
| 2002 | 9 | 0 |
| 2003 | 9 | 0 |
| 2004 | 14 | 0 |
| 2005 | 8 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081107 | Caspian Spinal System, Screws, Rods, Hooks, Rod ConnectorsSummary page 1…MNI, MNH Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K08 1107) * K2M Range Spinal System (K070229, K072914, K080792, K081381, K410085 1, KI 12037, KI 12920) * K2M Caspian Spinal… | 2008 |
| * | K070229 | Range Spinal SystemSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K08 1107) * K2M Range Spinal System (K070229, K072914, K080792, K081381, K410085 1, KI 12037, KI 12920) * K2M Caspian Spinal System (K081 107, K092540, K093534, K41032… | 2007 |
| * | K072914 | Natural Bridge LP Transverse ConnectorsSummary page 1…1 3. Predicate or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K08 1107) * K2M Range Spinal System (K070229, K072914, K080792, K081381, K410085 1, KI 12037, KI 12920) * K2M Caspian Spinal System (K081 107, K092540, K093534, K4103232,141 13… | 2008 |
| * | K080792 | K2M Cocr RodSummary page 1…redicate or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K08 1107) * K2M Range Spinal System (K070229, K072914, K080792, K081381, K410085 1, KI 12037, KI 12920) * K2M Caspian Spinal System (K081 107, K092540, K093534, K4103232,141 13654)… | 2008 |
| * | K081381 | Range Spinal System, Large Denali ScrewsSummary page 1…or legally marketed devices which are substantially equivalent * K2M Everest Spinal System (K08 1107) * K2M Range Spinal System (K070229, K072914, K080792, K081381, K410085 1, KI 12037, KI 12920) * K2M Caspian Spinal System (K081 107, K092540, K093534, K4103232,141 13654) * fleP… | 2008 |
| * | K100851 | Range Spinal System | 2010 |
| * | K112037 | Range Spinal System (Mesa and Denali) | 2011 |
| * | K112920 | Range Spinal System (Mesa and Denali) | 2011 |
| * | K092540 | C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerSummary page 1…inal System (K08 1107) * K2M Range Spinal System (K070229, K072914, K080792, K081381, K410085 1, KI 12037, KI 12920) * K2M Caspian Spinal System (K081 107, K092540, K093534, K4103232,141 13654) * flePuy Mountaineer (KI 110353 4. Description of the device: The Everest Spinal… | 2010 |
| * | K093534 | Modification to Caspian Spinal SystemSummary page 1…em (K08 1107) * K2M Range Spinal System (K070229, K072914, K080792, K081381, K410085 1, KI 12037, KI 12920) * K2M Caspian Spinal System (K081 107, K092540, K093534, K4103232,141 13654) * flePuy Mountaineer (KI 110353 4. Description of the device: The Everest Spinal System is… | 2009 |
| * | K103232 | Caspian Spinal SystemSummary page 1…7) * K2M Range Spinal System (K070229, K072914, K080792, K081381, K410085 1, KI 12037, KI 12920) * K2M Caspian Spinal System (K081 107, K092540, K093534, K4103232,141 13654) * flePuy Mountaineer (KI 110353 4. Description of the device: The Everest Spinal System is a top-loa… | 2011 |
| * | K113654 | Caspian | 2012 |
| * | K110353 | Mountaineer Oct Spinal SystemSummary page 1…914, K080792, K081381, K410085 1, KI 12037, KI 12920) * K2M Caspian Spinal System (K081 107, K092540, K093534, K4103232,141 13654) * flePuy Mountaineer (KI 110353 4. Description of the device: The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lumb… | 2011 |
What descends from it? (43)
See all 434 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 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 113 ancestors have a recall of any class.
- Of its descendants, K132757 (K2m, Inc., 2013) has gone furthest, with 41 descendants of its own.
- 10 other devices also cite its predicate K081107.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 if used in conjunction with the Range (Mesa and Denali) Spinal Systems are: 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, kyphiosis; and/ar lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe…
Read the full statement (180 words)
The Everest Spinal System if used in conjunction with the Range (Mesa and Denali) Spinal Systems are:
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, kyphiosis; and/ar lordosis); tumor; pseudoarthrosis; 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 thoracolumnbar screw stabilization as an adjunct to fbision for the following indications: degenerative disc disease (DDD ) (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, .yphosis; and/or lordosis); tumor; pscudoartbrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120656: 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/K120656
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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