510(k) · Cleared
ClearedEVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · NKG Posterior Cervical Screw System
Cleared on Oct 5, 2018 as substantially equivalent to K181188 (K2m, Inc., 2018) and 3 other predicates after a 108-day review. Its family tree reaches back 23 generations to 1985. 1 of the 452 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Oct 5, 2018
- Review
- 108 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 23 generations to K853033 (1985). 446 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 2 citing it directly. 1 of the 452 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 19 generations between
- 3 generations backK151727 Everest Spinal SystemK2m, Inc. · 2015
- 2 generations backK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- 1 generation backK181188 EVEREST Spinal SystemK2m, Inc. · 2018
- This deviceK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
- Descendant · cites it directly · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- Descendant · 2 generations on · 1 of its ownK240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024
- Descendant · 2 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK241863 Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024
Show all 23 generations
- Root · 23 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 22 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 21 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 20 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 19 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 18 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 17 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 16 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 15 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 14 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 13 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 12 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 11 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 10 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 9 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 8 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 7 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 6 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 5 generations backK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 4 generations backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 3 generations backK151727 Everest Spinal SystemK2m, Inc. · 2015
- 2 generations backK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- 1 generation backK181188 EVEREST Spinal SystemK2m, Inc. · 2018
- This deviceK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
Class I recalls in this family
- K093670 Modification to: Oasys System6 generations back · 2010
Most influential descendants
Showing 5 of 5 · See all- K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · cites it directly4descendants
- K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · cites it directly1descendant
- K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024 · 2 generations on1descendant
- K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 2 generations on0descendants
- K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −22 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −21 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −20 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −19 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −18 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −17 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −16 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −15 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −14 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −13 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −12 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −11 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −10 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −9 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −8 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −7 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −6 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| −5 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −4 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −3 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| −2 | K161369 | EVEREST Spinal System | K2m, Incorporated | 2016 | — |
| −1 | K181188 | EVEREST Spinal System | K2m, Inc. | 2018 | — |
| 0 (this device) | K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT… | K2m, Inc. | 2018 | — |
| +1 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System… | Stryker Spine | 2023 | — |
| +1 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal… | Stryker Spine | 2024 | — |
| +2 | K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance | 2024 | — |
| +2 | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | — |
| +3 | K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 13 | 0 |
| 1999 | 13 | 0 |
| 2000 | 18 | 0 |
| 2001 | 32 | 0 |
| 2002 | 22 | 0 |
| 2003 | 24 | 0 |
| 2004 | 51 | 0 |
| 2005 | 36 | 0 |
| 2006 | 25 | 0 |
| 2007 | 22 | 0 |
| 2008 | 26 | 0 |
| 2009 | 23 | 0 |
| 2010 | 17 | 1 |
| 2011 | 21 | 0 |
| 2012 | 12 | 0 |
| 2013 | 10 | 0 |
| 2014 | 4 | 0 |
| 2015 | 13 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 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.
1 device in this family has a Class I recall. 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181188 | EVEREST Spinal SystemSummary page 9…adel, polypropelene, acetal copolymer, or silicone in the handles or retractor blades Primary Predicate: EVEREST Spinal System (K2M Inc. – K181188) Additional Predicates: RANGE (MESA and DENALI) Spinal System (K2M Inc. – K171832), CASPIAN OCT (MESA… | 2018 |
| * | K171832 | Range/Denali/Mesa Spinal SystemSummary page 9…andles or retractor blades Primary Predicate: EVEREST Spinal System (K2M Inc. – K181188) Additional Predicates: RANGE (MESA and DENALI) Spinal System (K2M Inc. – K171832), CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System (K2M Inc. – K153370), Y… | 2017 |
| * | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemSummary page 9…(MESA and DENALI) Spinal System (K2M Inc. – K171832), CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System (K2M Inc. – K153370), YUKON OCT Spinal System (K2M Inc. – K171444) Reference Devices: Vertex™ Reconstruction System (Medtronic Sofamor Danek US… | 2016 |
| * | K171444 | YUKON OCT Spinal SystemSummary page 9…71832), CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System (K2M Inc. – K153370), YUKON OCT Spinal System (K2M Inc. – K171444) Reference Devices: Vertex™ Reconstruction System (Medtronic Sofamor Danek USA , Inc. – K180851),… | 2017 |
| † | K180851 | VERTEX™ Reconstruction System | 2018 |
| † | K171791 | MAGEC® System | 2017 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 43 of the 446 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K222684 (Stryker Spine, 2023) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
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 (649 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.
Range (Mesa and Denali) and ARI 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 Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach
The Caspian OCT/MESA Mini/DENALI Mini Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Caspian OCT/MESA Mini/DENALI Mini Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/DENALI Mini Spinal System may be connected to Range/MESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods.
The YUKON OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Clto C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The YUKON OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the YUKON OCT Spinal System may be connected to Everest Spinal System components via the rod to rod connectors or transition rods
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181603: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT 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/K181603
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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