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 Apr 11, 2019 after a 57-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Apr 11, 2019
- Review
- 57 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK190317 Zavation Spinal SystemZavation Medical Products, LLC · 2019
- Descendant · cites it directly · 4 of its ownK211113 Zavation Spinal SystemZavation Medical Products, LLC · 2021
- Descendant · 2 generations on · 3 of its ownK222614 Zavation Spinal SystemZavation Medical Products, LLC · 2022
- Descendant · 3 generations on · 1 of its ownK243908 Tiger 2 SystemZavation Medical Products, LLC · 2025
- Descendant · 4 generations on · 0 of its ownK253943 Tiger 2 SystemZavation Medical Products, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK231811 Zavation Connector SystemZavation Medical Products, LLC · 2023
Most influential descendants
Showing 5 of 5 · See all- K211113Zavation Spinal SystemZavation Medical Products, LLC · 2021 · cites it directly4descendants
- K222614Zavation Spinal SystemZavation Medical Products, LLC · 2022 · 2 generations on3descendants
- K243908Tiger 2 SystemZavation Medical Products, LLC · 2025 · 3 generations on1descendant
- K253943Tiger 2 SystemZavation Medical Products, LLC · 2026 · 4 generations on0descendants
- K231811Zavation Connector SystemZavation Medical Products, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190317 | Zavation Spinal System | Zavation Medical Products, LLC | 2019 | — |
| +1 | K211113 | Zavation Spinal System | Zavation Medical Products, LLC | 2021 | — |
| +2 | K222614 | Zavation Spinal System | Zavation Medical Products, LLC | 2022 | — |
| +3 | K243908 | Tiger 2 System | Zavation Medical Products, LLC | 2025 | — |
| +4 | K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026 | — |
| +3 | K231811 | Zavation Connector System | Zavation Medical Products, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
Planning a device in NKB? 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211113 | Zavation Spinal System | 2021 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211113 (Zavation Medical Products, LLC, 2021) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K190317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190317: 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/K190317
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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