510(k) · Cleared
ClearedVulcan Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 10, 2026 as substantially equivalent to K132757 (K2m, Inc., 2013) and 2 other predicates after an 88-day review. Its family tree reaches back 26 generations to 1985. 2 of the 838 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 10, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 26 generations to K853033 (1985). 837 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet. 2 of the 838 devices in this family, counting this one, have a Class I recall.
- Root · 26 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 22 generations between
- 3 generations backK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
- 2 generations backK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
- 1 generation backK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- This deviceK253545 Vulcan Spinal SystemK2m, Inc. · 2026
Show all 26 generations
- Root · 26 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 25 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 24 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 23 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 22 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 21 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 20 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 19 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 18 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 17 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 16 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 15 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 14 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 13 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 12 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 11 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 10 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 9 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 8 generations backK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 7 generations backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 6 generations backK151727 Everest Spinal SystemK2m, Inc. · 2015
- 5 generations backK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- 4 generations backK181188 EVEREST Spinal SystemK2m, Inc. · 2018
- 3 generations backK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
- 2 generations backK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
- 1 generation backK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- This deviceK253545 Vulcan Spinal SystemK2m, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −25 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −24 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −23 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −22 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −21 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −20 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −19 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −18 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −17 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −16 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −15 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −14 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −13 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −12 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −11 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −10 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −9 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| −8 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −7 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −6 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| −5 | K161369 | EVEREST Spinal System | K2m, Incorporated | 2016 | — |
| −4 | K181188 | EVEREST Spinal System | K2m, Inc. | 2018 | — |
| −3 | 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 | — |
| −1 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal… | Stryker Spine | 2024 | — |
| 0 (this device) | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 7 | 0 |
| 1994 | 5 | 0 |
| 1995 | 11 | 0 |
| 1996 | 11 | 0 |
| 1997 | 12 | 0 |
| 1998 | 16 | 0 |
| 1999 | 15 | 0 |
| 2000 | 30 | 0 |
| 2001 | 42 | 0 |
| 2002 | 37 | 0 |
| 2003 | 40 | 0 |
| 2004 | 72 | 0 |
| 2005 | 55 | 0 |
| 2006 | 49 | 0 |
| 2007 | 48 | 0 |
| 2008 | 80 | 1 |
| 2009 | 51 | 0 |
| 2010 | 39 | 1 |
| 2011 | 46 | 0 |
| 2012 | 32 | 0 |
| 2013 | 26 | 0 |
| 2014 | 21 | 0 |
| 2015 | 24 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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.
2 devices in this family have 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K132757 | Everest Spinal SystemSummary page 5…em Product Code: NKB Predicate Devices: Vulcan Spinal System: Primary Predicate: Everest Spinal System (K132757, K242361) Additional Predicates: Xia 3 System – Serrato (K170496, K… | 2013 |
| * | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Summary page 5…t Code: NKB Predicate Devices: Vulcan Spinal System: Primary Predicate: Everest Spinal System (K132757, K242361) Additional Predicates: Xia 3 System – Serrato (K170496, K242361)… | 2024 |
| * | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessorySummary page 5…Primary Predicate: Everest Spinal System (K132757, K242361) Additional Predicates: Xia 3 System – Serrato (K170496, K242361) Reference Device: Olympic Posterior Spinal Fixation Syste… | 2017 |
| † | K153446 | OLYMPIC Posterior Spinal Fixation System | 2016 |
| † | K143334 | Range/Denali/Mesa Spinal System | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 41 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 94 of the 837 ancestors have a recall of any class; 2 have a Class I recall.
- 4 other devices also cite its predicate K132757.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Vulcan Spinal System is intended for posterior, non-cervical, pedicle fixation as an adjunct to fusion 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, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed…
Read the full statement (171 words)
The Vulcan Spinal System is intended for posterior, non-cervical, pedicle fixation as an adjunct to fusion 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, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vulcan Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Vulcan Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Refer to the Compatibility section of the VB Spine Vulcan Spinal System Instructions for Use for a listing of compatible systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253545: Vulcan 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/K253545
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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