510(k) · Cleared
ClearedVital™ Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Highridge Medical, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 17, 2025 as substantially equivalent to K240539 (Zimvie Spine (Zimmer Biomet Spine, Inc.), 2024) and 1 other predicate after an 85-day review. Its family tree reaches back 25 generations to 2004. 1 of the 428 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 17, 2025
- Review
- 85 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K040583 (2004). 427 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 428 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations between
- 3 generations backK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
- 2 generations backK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
- 1 generation backK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
- This deviceK253093 Vital™ Spinal Fixation SystemHighridge Medical, LLC · 2025
Show all 25 generations
- Root · 25 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 24 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 23 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 22 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 21 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 20 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 19 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 18 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 17 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 16 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 15 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 14 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 13 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 12 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 11 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 10 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 9 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 8 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- 7 generations backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
- 6 generations backK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
- 5 generations backK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
- 4 generations backK210637 CD Horizon™ Spinal SystemMedtronic · 2021
- 3 generations backK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
- 2 generations backK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
- 1 generation backK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
- This deviceK253093 Vital™ Spinal Fixation SystemHighridge Medical, LLC · 2025
Class I recalls in this family
- K100952 Modification to Synthes Matrix System8 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −24 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −23 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −22 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −21 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −20 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −19 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −18 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −17 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −16 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −15 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −14 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −13 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −12 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −11 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −10 | K143019 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −9 | K153463 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −8 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2017 | — |
| −7 | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −6 | K193011 | CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| −5 | K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™… | Medtronic | 2020 | — |
| −4 | K210637 | CD Horizon™ Spinal System | Medtronic | 2021 | — |
| −3 | K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −2 | K223181 | NuVasive Reline System | Nu Vasive, Incorporated | 2023 | — |
| −1 | K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2023 | — |
| 0 (this device) | K253093 | Vital™ Spinal Fixation System | Highridge Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 14 | 0 |
| 1996 | 9 | 0 |
| 1997 | 10 | 0 |
| 1998 | 17 | 0 |
| 1999 | 14 | 0 |
| 2000 | 25 | 0 |
| 2001 | 31 | 0 |
| 2002 | 22 | 0 |
| 2003 | 23 | 0 |
| 2004 | 37 | 0 |
| 2005 | 27 | 0 |
| 2006 | 21 | 0 |
| 2007 | 18 | 0 |
| 2008 | 22 | 0 |
| 2009 | 12 | 0 |
| 2010 | 13 | 1 |
| 2011 | 12 | 0 |
| 2012 | 3 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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? (2)
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 |
|---|---|---|---|
| * | K240539 | Vital™ Spinal Fixation SystemSummary page 5…screw system (NKB, KWP, KWQ) Predicate Devices Primary: Vital™ Spinal Fixation System (K240539) Additional: KHEIRON® Spinal Fixation System,… | 2024 |
| * | K232650 | KHEIRON® Spinal Fixation System, including patient specific K-RODSummary page 5…ion System, including patient specific K-ROD (K232650) Device Description The Vital™ (Vitality) Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to a… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 8 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 7 months on median.
- 50 of the 427 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K240539.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Vital Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1S2/ilium), posterior hook fixation (T1L5), or anterolateral fixation (T8L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with…
Read the full statement (366 words)
The Vital Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1S2/ilium), posterior hook fixation (T1L5), or anterolateral fixation (T8L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vital Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5 S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vital System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vital System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
PRODUCT COMPATIBILITY
The use of the Vital Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® JavaT r Spinal Fixation System hooks, APEX Spinal SystemT " hooks, or fixation of the Universal Clamp@ Spinal Fixation System to the rods of the Vital Spinal Fixation System. The Vital Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System.
The Vital Spinal Fixation System implants are compatible with the KHEIRON@ Spinal Fixation System patient specific K-ROD when used in posterior approach.
In order to achieve additional levels of fixation in skeletally mature patients, the Vital Spinal Fixation System may be connected to the Virage@ OCT Spinal Fixation System and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253093 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253093: Vital™ Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253093
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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