510(k) · Cleared
Recalled · Class II · 2020Yukon 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 Feb 7, 2020 as substantially equivalent to K182182 (K2m, 2018) and 4 other predicates after an 87-day review. Its family tree reaches back 19 generations to 1985. 1 of the 268 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Feb 7, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- NKG
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 19 generations to K853033 (1985). 267 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 268 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations between
- 3 generations backK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
- 2 generations backK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- 1 generation backK182182 YUKON OCT Spinal SystemK2m · 2018
- This deviceK193129 Yukon OCT Spinal SystemK2m, Inc. · 2020
Show all 19 generations
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 18 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 17 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 16 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 15 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 14 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 13 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 12 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 11 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 10 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 9 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 8 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 7 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 6 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 5 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- 4 generations backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- 3 generations backK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
- 2 generations backK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- 1 generation backK182182 YUKON OCT Spinal SystemK2m · 2018
- This deviceK193129 Yukon OCT Spinal SystemK2m, Inc. · 2020
Class I recalls in this family
- K093670 Modification to: Oasys System7 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −18 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −17 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −16 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −15 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −14 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −13 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −12 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −11 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −10 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −9 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −8 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −7 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −6 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −5 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| −4 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| −3 | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m, Incorporated | 2016 | — |
| −2 | K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017 | 3 |
| −1 | K182182 | YUKON OCT Spinal System | K2m | 2018 | — |
| 0 (this device) | K193129 | Yukon OCT Spinal System | K2m, 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 | 20 | 0 |
| 2002 | 13 | 0 |
| 2003 | 15 | 0 |
| 2004 | 35 | 0 |
| 2005 | 28 | 0 |
| 2006 | 18 | 0 |
| 2007 | 12 | 0 |
| 2008 | 19 | 0 |
| 2009 | 16 | 0 |
| 2010 | 7 | 1 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 10 | 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? (5)
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 |
|---|---|---|---|
| * | K182182 | YUKON OCT Spinal SystemSummary page 4…21 CFR 888.3075 Product Code: NKG, KWP Predicate Device: Primary Predicate: K2M Yukon OCT Spinal System (K182182 & K171444) Additional Predicates: Stryker OASYS (K080143 & K032394)… | 2018 |
| * | K171444 | YUKON OCT Spinal SystemSummary page 4…CFR 888.3075 Product Code: NKG, KWP Predicate Device: Primary Predicate: K2M Yukon OCT Spinal System (K182182 & K171444) Additional Predicates: Stryker OASYS (K080143 & K032394)… | 2017 |
| * | K080143 | Modification to Stryker Spine Oasys SystemSummary page 4…K2M Yukon OCT Spinal System (K182182 & K171444) Additional Predicates: Stryker OASYS (K080143 & K032394) DePuy Mountaineer (K042508) Reference Devices:… | 2008 |
| * | K032394 | Stryker Spine Oasys SystemSummary page 4…K2M Yukon OCT Spinal System (K182182 & K171444) Additional Predicates: Stryker OASYS (K080143 & K032394) DePuy Mountaineer (K042508) Reference Devices:… | 2004 |
| * | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemSummary page 4…4) Additional Predicates: Stryker OASYS (K080143 & K032394) DePuy Mountaineer (K042508) Reference Devices: K2M Everest Spinal System (K161369) Device Descr… | 2004 |
| † | K161369 | EVEREST Spinal System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2020 | Class II | Z-0520-2021 | Nonconforming Material/Component | Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on. |
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 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 24 of the 267 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K182182.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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 fusion (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative…
Read the full statement (172 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 fusion (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 absences 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, MESA, and DENALI Spinal System components via the rod to rod connectors or transition rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193129: 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/K193129
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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