510(k) · Cleared
ClearedCaspian OCT/MESA Mini/DENALI Mini Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Incorporated · NKG Posterior Cervical Screw System
Cleared on Feb 16, 2016 as substantially equivalent to K150474 (Nu Vasive, Incorporated, 2015) and 6 other predicates after an 85-day review. Its family tree reaches back 16 generations to 1985. 1 of the 242 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Feb 16, 2016
- Review
- 85 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 16 generations to K853033 (1985). 224 ancestors in all, the oldest K781443 (1978). 17 later devices descend from it, 4 citing it directly. 1 of the 242 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 2 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- 1 generation backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- This deviceK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
- Descendant · cites it directly · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK182182 YUKON OCT Spinal SystemK2m · 2018
- Descendant · cites it directly · 5 of its ownK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
- Descendant · 2 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
Show all 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 3 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 2 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- 1 generation backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- This deviceK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093670 Modification to: Oasys System5 generations back · 2010
Most influential descendants
Showing 5 of 17 · See all- K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · cites it directly13descendants
- K182182YUKON OCT Spinal SystemK2m · 2018 · cites it directly5descendants
- K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc. · 2018 · cites it directly5descendants
- K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · 2 generations on4descendants
- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −3 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −2 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| −1 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| 0 (this device) | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m, Incorporated | 2016 | — |
| +1 | K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017 | 3 |
| +1 | K182182 | YUKON OCT Spinal System | K2m | 2018 | — |
| +1 | K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT… | K2m, Inc. | 2018 | — |
| +2 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System… | Stryker Spine | 2023 | — |
| +2 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
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 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 19 | 0 |
| 2002 | 11 | 0 |
| 2003 | 12 | 0 |
| 2004 | 27 | 0 |
| 2005 | 24 | 0 |
| 2006 | 10 | 0 |
| 2007 | 9 | 0 |
| 2008 | 16 | 0 |
| 2009 | 12 | 0 |
| 2010 | 7 | 1 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 9 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K150474 | NuVasive VuePoint II OCT System | 2015 |
| * | K081107 | Caspian Spinal System, Screws, Rods, Hooks, Rod ConnectorsSummary page 4…Code KWP) Predicate Device(s) Primary Predicate: Nuvasive VuePoint II OCT System (Kl50474) Additional Predicates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K081107) K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (Kl33288) Medtronic Vertex Reconstruction System (K152338) Stryker Oasys Sys… | 2008 |
| * | K133288 | Caspian Oct Spinal System | 2014 |
| * | K152338 | VERTEX (r) Reconstruction SystemSummary page 4…ates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K081107) K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (Kl33288) Medtronic Vertex Reconstruction System (K152338) Stryker Oasys System (K151755) DePuy Summit SI OCT Spinal Fixaiton System, Mountaineer OCT Spinal System (K151885) Globus Ellips… | 2015 |
| * | K151755 | OASYS (r) SystemSummary page 4…/DENALI Mini Spinal System (K081107) K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (Kl33288) Medtronic Vertex Reconstruction System (K152338) Stryker Oasys System (K151755) DePuy Summit SI OCT Spinal Fixaiton System, Mountaineer OCT Spinal System (K151885) Globus Ellipse and Protex CT Occipitio-Cervi… | 2015 |
| * | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemSummary page 4…stem (Kl33288) Medtronic Vertex Reconstruction System (K152338) Stryker Oasys System (K151755) DePuy Summit SI OCT Spinal Fixaiton System, Mountaineer OCT Spinal System (K151885) Globus Ellipse and Protex CT Occipitio-Cervico-Thoracic Spinal Systems (K150552) Device Description The Caspian OCT/MESA Mini/… | 2015 |
| * | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSSummary page 4…tem (K151755) DePuy Summit SI OCT Spinal Fixaiton System, Mountaineer OCT Spinal System (K151885) Globus Ellipse and Protex CT Occipitio-Cervico-Thoracic Spinal Systems (K150552) Device Description The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loading, multiple component, posterior (occipi… | 2015 |
What descends from it? (17)
See all 174 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 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 18 of the 224 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K171444 (K2m, Inc., 2017) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K150474.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 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…
Read the full statement (179 words)
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.
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/K153370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153370: Caspian OCT/MESA Mini/DENALI Mini 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/K153370
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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