510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

YUKON OCT Spinal System

K171444510(k) TraditionalCleared Aug 8, 201784-day reviewClass II21 CFR 888.3075Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

K2m, Inc. · NKG Posterior Cervical Screw System

Cleared on Aug 8, 2017 as substantially equivalent to K081107 (K2m, Inc., 2008) and 11 other predicates after an 84-day review. Its family tree reaches back 17 generations to 1985. 1 of the 279 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it. It has been recalled 3 times.

Decided
Aug 8, 2017
Review
84 days
Class
Class II
Product code
NKG
Recalls
3
Predicates
12

Its longest line of descent runs back 17 generations to K853033 (1985). 265 ancestors in all, the oldest K781443 (1978). 13 later devices descend from it, 4 citing it directly. 1 of the 279 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2015: 10 other ancestors2014: 2 other ancestors2011: 6 other ancestors2010: 7 other ancestors, 1 with a Class I recall12008: 19 other ancestors2005: 28 other ancestors2004: 35 other ancestors1999: 8 other ancestors2013: 1 other ancestor2009: 16 other ancestors2007: 12 other ancestors2003: 15 other ancestors2002: 13 other ancestors2001: 20 other ancestors2006: 18 other ancestors2000: 11 other ancestors1997: 5 other ancestors2012: 2 other ancestors1998: 7 other ancestors1996: 5 other ancestors1995: 4 other ancestors1994: 1 other ancestor1993: 1 other ancestor1984: 1 other ancestor1978: 1 other ancestor2018: 2 descendants cleared2020: 3 descendants cleared2022: 1 descendant cleared2024: 3 descendants cleared2023: 1 descendant cleared2026: 3 descendants clearedReference device: K161369 · EVEREST Spinal System · K2m, Incorporated · 2016Reference device: K141147 · Range Spinal System · K2m, Inc. · 2014K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001×2: 2 generations cleared close together, K022190 (2002), K030103 (2003) K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004×3: 3 generations cleared close together, K062174 (2006), K063156 (2006), K063741 (2007) K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K101070 · Expedium Spine System · Medos International SARL · 2010 · recalled×2: 2 generations cleared close together, K122226 (2012), K123783 (2013) K150552 · ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS · Globus Medical, Inc. · 2015 · recalledK153370 · Caspian OCT/MESA Mini/DENALI Mini Spinal System · K2m, Incorporated · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 24 other ancestors3 generations back: 21 other ancestors4 generations back: 15 other ancestors5 generations back: 24 other ancestors6 generations back: 39 other ancestors, 1 with a Class I recall17 generations back: 53 other ancestors8 generations back: 39 other ancestors9 generations back: 14 other ancestors10 generations back: 6 other ancestors11 generations back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K153370 · Caspian OCT/MESA Mini/DENALI Mini Spinal System · K2m, Incorporated · 2016K150552 · ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS · Globus Medical, Inc. · 2015 · recalledK123783 · Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants · Globus Medical, Inc. · 2013K122226 · Revere Stabilization System · Globus Medical, Inc. · 2012K101070 · Expedium Spine System · Medos International SARL · 2010 · recalledK080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K063741 · Expedium Spine System · Depuy Spine, Inc. · 2007K063156 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−15−10−50
  1. Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 13 generations between
  3. 3 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
  4. 2 generations backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
  5. 1 generation backK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
  6. This deviceK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017
  7. Descendant · cites it directly · 5 of its ownK182182 YUKON OCT Spinal SystemK2m · 2018
  8. Descendant · cites it directly · 5 of its ownK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
  9. Descendant · 2 generations on · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
  10. Descendant · 2 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
  11. Descendant · 3 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
Show all 17 generations
  1. Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 16 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 15 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 14 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 13 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 12 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 11 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 10 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 9 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 8 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 7 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 6 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 5 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
  14. 4 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
  15. 3 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
  16. 2 generations backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
  17. 1 generation backK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
  18. This deviceK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2018: 22020: 32022: 12023: 12024: 32026: 3
2018high 3 (2020) · low 0 (2019)2026

Class I recalls in this family

  • K093670 Modification to: Oasys System6 generations back · 2010

Most influential descendants

Showing 5 of 13 · See all
  • 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
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−16K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−15K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−14K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−13K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−12K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−11K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−10K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−9K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−8K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−7K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−6K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−5K101070Expedium Spine SystemMedos International SARL20101
−4K122226Revere Stabilization SystemGlobus Medical, Inc.2012—
−3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.2013—
−2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.20151
−1K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated2016—
0 (this device)K171444YUKON OCT Spinal SystemK2m, Inc.2017—
+1K182182YUKON OCT Spinal SystemK2m2018—
+1K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT…K2m, Inc.2018—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System…Stryker Spine2023—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.2020—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For…Alphatec Spine, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199310
199410
199540
199650
199750
199870
199980
2000110
2001200
2002130
2003150
2004350
2005280
2006180
2007120
2008190
2009160
201071
201160
201220
201310
201420
2015100

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
202030
202210
202310
202430
202630
FIG. 1 — Lineage of K171444, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (12)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K081107Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors
Summary page 4
…ppliance, fixation, spinal interlaminal (21 CFR 888.3050, Product Code KWP) Predicate Device(s) Primary Predicate: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (081107) Additional Predicates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084, K153370) DePuy Mountaineer (K042508, K1103…
K2m, Inc.2008—
*K101084Caspian Spinal System
Summary page 4
…te Device(s) Primary Predicate: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (081107) Additional Predicates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipita…
K2m, Inc.2010—
*K153370Caspian OCT/MESA Mini/DENALI Mini Spinal System
Summary page 4
…(s) Primary Predicate: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (081107) Additional Predicates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Pla…
K2m, Incorporated2016—
*K042508Sumit Oct Spinal System and Mountaineer Oct Spinal System
Summary page 4
…aspian OCT/MESA Mini/DENALI Mini Spinal System (081107) Additional Predicates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K9843…
Depuy Spine, Inc.2004—
*K110353Mountaineer Oct Spinal System
Summary page 4
…T/MESA Mini/DENALI Mini Spinal System (081107) Additional Predicates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K984377) Medtr…
Depuy Spine, Inc.2011—
*K133556Virage Oct Spinal Fixation System
Summary page 4
…Spinal System (081107) Additional Predicates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K984377) Medtronic Vertex (K052402, K0…
Zimmer Spine, Inc.20142
*K151224Lineum OCT Spine System
Summary page 4
…Additional Predicates: K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K984377) Medtronic Vertex (K052402, K083071) Reference Device…
Biomet Spine20151
*K142838Synapse Occipital-Cervical-Thoracic (OCT) System
Summary page 4
…Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K984377) Medtronic Vertex (K052402, K083071) Reference Devices: K2M Everest Spinal Syst…
Synthes USA Products, LLC20151
*K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook System
Summary page 4
…l System (K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K984377) Medtronic Vertex (K052402, K083071) Reference Devices: K2M Everest Spinal System (K161369) K2M Range/Mesa/Denali (K141…
Synthes (Usa)1998—
*K984377Synthes Spine Cervifix System
Summary page 4
…(K101084, K153370) DePuy Mountaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K984377) Medtronic Vertex (K052402, K083071) Reference Devices: K2M Everest Spinal System (K161369) K2M Range/Mesa/Denali (K141147) Dev…
Synthes (Usa)1999—
*K052402Vertex Reconstruction System
Summary page 4
…untaineer (K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K984377) Medtronic Vertex (K052402, K083071) Reference Devices: K2M Everest Spinal System (K161369) K2M Range/Mesa/Denali (K141147) Device Description The YUKON O…
Medtronic Sofamor Danek2005—
*K083071Vertex Reconstruction System
Summary page 4
…(K042508, K110353) Zimmer Virage (K133556) Biomet Lineum (K151224) Synthes Synapse (K142838) Occipital Rod/Plate, CerviFix (K982322, K984377) Medtronic Vertex (K052402, K083071) Reference Devices: K2M Everest Spinal System (K161369) K2M Range/Mesa/Denali (K141147) Device Description The YUKON OCT Spinal…
Medtronic Sofamor Danek20081
†K161369EVEREST Spinal SystemK2m, Incorporated2016—
†K141147Range Spinal SystemK2m, Inc.2014—

Also cleared against K081107: 10 other devices →

What descends from it? (13)

See all 13

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K182182YUKON OCT Spinal SystemK2m20185
K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185
K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220
K193129Yukon OCT Spinal SystemK2m, Inc.20200

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 13, 2022Class IIZ-1307-2022Under Investigation by firmSome of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue…
Dec 14, 2020Class IIZ-0931-2021Employee errorThe Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
Jul 24, 2018Class IIZ-0110-2020Process controlScrews had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action…

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 32 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
  • 23 of the 265 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K182182 (K2m, 2018) has gone furthest, with 5 descendants of its own.
  • 10 other devices also cite its predicate K081107.

How does its category compare?

All NKG devices

NKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · NKG

6in 2025

2015: 172016: 162017: 152018: 122019: 82020: 142021: 72022: 72023: 102024: 32025: 62026 (partial year): 4
2007high 17 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKG

58in 2025

2015: 71 days median2016: 87 days median2017: 108 days median2018: 61 days median2019: 50 days median2020: 59 days median2021: 56 days median2022: 108 days median2023: 58 days median2024: 100 days median2025: 58 days median2026 (partial year): 169 days median
2007high 169 (2026) · low 50 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKG

2in 2020

2018: 12019: 12020: 2
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NKG

153in 2025

2015: 42016: 732017: 992018: 1272019: 2142020: 2362021: 7042022: 1752023: 1312024: 2062025: 153
2007high 704 (2021) · low 0 (2007)2025

MAUDE reports naming product code NKG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
2015177104
20161687073
201715108099
201812611127
20198501214
202014592236
20217560704
202271080175
202310580131
202431000206
20256580153
202641690—

What is it indicated for?

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 (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…

Read the full statement (169 words)

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 (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 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.

Also cleared against K081107

10 other devices cite the same predicate.

  • K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
  • K151727Everest Spinal SystemK2m, Inc. · 2015
  • K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m · 2014
  • K141284Caspian Spinal SystemK2m, Inc. · 2014
  • K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC · 2013
  • K121808Casian, 3.5/4.5 ConnectorsK2m, Inc. · 2012

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

  • K260546Q Pedicle InstrumentsK2m, Inc. · 2026
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026
  • K252873Q Interbody InstrumentsK2m, Inc. · 2026
  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

Recent decisions in NKG

The NKG category page

  • K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026
  • K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2026
  • K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025

https://510kreport.com/device/K171444 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171444: 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/K171444

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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