510(k) · Cleared
ClearedLaguna Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phygen, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 2, 2011 as substantially equivalent to K083826 (Allez Spine, LLC, 2009) and 3 other predicates after a 69-day review. Its family tree reaches back 3 generations to 1999. 15 later devices descend from it.
- Decided
- Mar 2, 2011
- Review
- 69 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K981676 (1999). 5 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- 2 generations backK050060 Laguna Pedicle Screw SystemAllez Spine, LLC · 2005 · Recalled
- 1 generation backK072678 Laguna Size 8 Pedicle ScrewAllez Spine, LLC · 2008
- This deviceK103748 Laguna Pedicle Screw SystemPhygen, LLC · 2011
- Descendant · cites it directly · 14 of its ownK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012
- Descendant · 2 generations on · 6 of its ownK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
- Descendant · 2 generations on · 5 of its ownK152781 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016
- Descendant · 3 generations on · 3 of its ownK212066 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021
- Descendant · 3 generations on · 3 of its ownK151116 CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K122332Towerlox Pedicle Screw SystemCaptiva Spine · 2012 · cites it directly14descendants
- K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013 · 2 generations on6descendants
- K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016 · 2 generations on5descendants
- K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021 · 3 generations on3descendants
- K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| −2 | K050060 | Laguna Pedicle Screw System | Allez Spine, LLC | 2005 | 27 |
| −1 | K072678 | Laguna Size 8 Pedicle Screw | Allez Spine, LLC | 2008 | — |
| 0 (this device) | K103748 | Laguna Pedicle Screw System | Phygen, LLC | 2011 | — |
| +1 | K122332 | Towerlox Pedicle Screw System | Captiva Spine | 2012 | — |
| +2 | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw System | Captiva Spine | 2013 | — |
| +2 | K152781 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2016 | — |
| +3 | K212066 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2021 | — |
| +3 | K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K083826 | Laguna Polyaxial Pedicle Screw SystemSummary page 1…1 36. Equivalence: The modified LAGUNA@ Pedicle Screw System is substantially equivalent to the original LAGUNA® Pedicle Screw System (1(083826, K(09 1995, K(050060, K(072678), which are manufactured and marketed by Phygen,LLC. Indications:… | 2009 |
| * | K091995 | Laguna Size 8 Pedicle Screw System | 2009 |
| * | K050060 | Laguna Pedicle Screw SystemSummary page 1…GUNA@ Pedicle Screw System is substantially equivalent to the original LAGUNA® Pedicle Screw System (1(083826, K(09 1995, K(050060, K(072678), which are manufactured and marketed by Phygen,LLC. Indications: The LAGUNA®D Pedicle Screw System is intend… | 2005 |
| * | K072678 | Laguna Size 8 Pedicle ScrewSummary page 1…cle Screw System is substantially equivalent to the original LAGUNA® Pedicle Screw System (1(083826, K(09 1995, K(050060, K(072678), which are manufactured and marketed by Phygen,LLC. Indications: The LAGUNA®D Pedicle Screw System is intended to be u… | 2008 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122332 | Towerlox Pedicle Screw System | 2012 | 14 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K122332 (Captiva Spine, 2012) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K083826.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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®D 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); tumors; pseudlarthrosis; and/or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103748: Laguna Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103748
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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