510(k) · Cleared
Recalled · Class II · 2014Newport Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 13, 2009 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 65 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 13, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 2
- Predicates
- 0
65 later devices descend from it, 3 citing it directly.
- This deviceK083089 Newport Spinal SystemSeaspine, Inc. · 2009
- Descendant · cites it directly · 60 of its ownK160902 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016
- Descendant · 2 generations on · 56 of its ownK173882 SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · Recalled
- Descendant · 2 generations on · 49 of its ownK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 2 generations on · 47 of its ownK211606 Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · Recalled
- Descendant · 3 generations on · 46 of its ownK212692 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016 · cites it directly60descendants
- K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on56descendants
- K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on49descendants
- K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · 2 generations on47descendants
- K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021 · 3 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083089 | Newport Spinal System | Seaspine, Inc. | 2009 | — |
| +1 | K160902 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2016 | — |
| +2 | K173882 | SeaSpine Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2018 | 1 |
| +2 | K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2019 | — |
| +2 | K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | 2021 | 1 |
| +3 | K212692 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 14 | 0 |
| 2026 | 15 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (65)
See all 653 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2014 | Class II | Z-2182-2014 | Under Investigation by firm | Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery. |
| Jun 9, 2014 | Class II | Z-1961-2014 | Under Investigation by firm | Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K160902 (SeaSpine Orthopedics Corporation, 2016) has gone furthest, with 60 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. 2009, 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/K083089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083089: Newport Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083089
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026