510(k) · Cleared
ClearedZavation Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation Medical Products, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 18, 2019 as substantially equivalent to K153404 (Zavation, LLC, 2016) after a 31-day review. Its family tree reaches back 12 generations to 2004. 1 of the 204 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 18, 2019
- Review
- 31 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K040583 (2004). 203 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 204 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations between
- 3 generations backK113529 CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek · 2012
- 2 generations backK120838 Synthes Matrix SystemSynthes Spine · 2012
- 1 generation backK153404 Zavation Spinal SystemZavation, LLC · 2016
- This deviceK190361 Zavation Spinal SystemZavation Medical Products, LLC · 2019
Show all 12 generations
- Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 9 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 8 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 7 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 6 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 4 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 3 generations backK113529 CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek · 2012
- 2 generations backK120838 Synthes Matrix SystemSynthes Spine · 2012
- 1 generation backK153404 Zavation Spinal SystemZavation, LLC · 2016
- This deviceK190361 Zavation Spinal SystemZavation Medical Products, LLC · 2019
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −9 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −8 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −7 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −6 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −4 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −3 | K113529 | CD Horizon Voyager Spinal System | Medtronic Sofamor Danek | 2012 | — |
| −2 | K120838 | Synthes Matrix System | Synthes Spine | 2012 | — |
| −1 | K153404 | Zavation Spinal System | Zavation, LLC | 2016 | — |
| 0 (this device) | K190361 | Zavation Spinal System | Zavation Medical Products, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 10 | 0 |
| 1999 | 8 | 0 |
| 2000 | 17 | 0 |
| 2001 | 12 | 0 |
| 2002 | 13 | 0 |
| 2003 | 15 | 0 |
| 2004 | 18 | 0 |
| 2005 | 16 | 0 |
| 2006 | 10 | 0 |
| 2007 | 9 | 0 |
| 2008 | 10 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 1 |
| 2011 | 6 | 0 |
| 2012 | 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? (1)
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 |
|---|---|---|---|
| * | K153404 | Zavation Spinal SystemSummary page 4…Orthopedic Product code: NKB, KWQ Basis for submission: Addition of new components Prior Submissions: K112484 and K153404. Both received Substantial Equivalence determinations Device Description: The Zavation Spinal S… | 2016 |
| † | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®… | 2018 |
| † | K132126 | Spectrum Spine Fenestrated Facet Screw System | 2013 |
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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 27 of the 203 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Zavation Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: 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.c., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
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/K190361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190361: Zavation 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/K190361
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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