510(k) · Cleared
ClearedLaguna Size 8 Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allez Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 7, 2009 after a 36-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Aug 7, 2009
- Review
- 36 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK091995 Laguna Size 8 Pedicle Screw SystemAllez Spine, LLC · 2009
- Descendant · cites it directly · 15 of its ownK103748 Laguna Pedicle Screw SystemPhygen, LLC · 2011
- Descendant · 2 generations on · 14 of its ownK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012
- Descendant · 3 generations on · 6 of its ownK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
- Descendant · 3 generations on · 5 of its ownK152781 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016
- Descendant · 4 generations on · 3 of its ownK212066 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K103748Laguna Pedicle Screw SystemPhygen, LLC · 2011 · cites it directly15descendants
- K122332Towerlox Pedicle Screw SystemCaptiva Spine · 2012 · 2 generations on14descendants
- K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013 · 3 generations on6descendants
- K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016 · 3 generations on5descendants
- K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091995 | Laguna Size 8 Pedicle Screw System | Allez Spine, LLC | 2009 | — |
| +1 | K103748 | Laguna Pedicle Screw System | Phygen, LLC | 2011 | — |
| +2 | K122332 | Towerlox Pedicle Screw System | Captiva Spine | 2012 | — |
| +3 | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw System | Captiva Spine | 2013 | — |
| +3 | K152781 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2016 | — |
| +4 | K212066 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | — | LAGUNA® Size 8 Pedicle Screw System Named without a submission number |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103748 | Laguna Pedicle Screw System | 2011 | 15 |
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, K103748 (Phygen, LLC, 2011) has gone furthest, with 15 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 | — |
What is it indicated for?
The LAGUNA® Size 8 Pedicle Screw System is intended to be used as an adjunct to fusion in skeletally mature patients using autograft or allograft in posterior, non-cervical fixation for the following conditions: degenerative disc disease (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 and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091995 · printed Nov 3, 2026
Cite this page
510(k) Report. “K091995: Laguna Size 8 Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K091995
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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