510(k) · Cleared
Recalled · 2008Laguna Monoaxial 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 Dec 9, 2005 as substantially equivalent to K050060 (Allez Spine, LLC, 2005) after a 206-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it. It has been recalled 21 times.
- Decided
- Dec 9, 2005
- Review
- 206 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 21
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981676 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- 1 generation backK050060 Laguna Pedicle Screw SystemAllez Spine, LLC · 2005 · Recalled
- This deviceK051275 Laguna Monoaxial Pedicle Screw SystemAllez Spine, LLC · 2005
- Descendant · cites it directly · 0 of its ownK110679 Del Mar Monoaxial Pedicle Screw SystemPhygen, LLC · 2011
Most influential descendants
Showing 1 of 1 · See all- K110679Del Mar Monoaxial Pedicle Screw SystemPhygen, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| −1 | K050060 | Laguna Pedicle Screw System | Allez Spine, LLC | 2005 | 27 |
| 0 (this device) | K051275 | Laguna Monoaxial Pedicle Screw System | Allez Spine, LLC | 2005 | — |
| +1 | K110679 | Del Mar Monoaxial Pedicle Screw System | Phygen, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K050060 | Laguna Pedicle Screw SystemSummary page 1…ially equivalent to the LagunaTM (polyaxial) Pedicle Screw System, which is manufactured and marketed by Allez Spine, LLC - K050060 S/E May 4, 2005 Indications: The Laguna Spinal System is intended for posterior, non-cervical fi… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110679 | Del Mar Monoaxial Pedicle Screw System | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2008 | Not classified | Z-0154-2009 | Pending | This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing… |
| Apr 14, 2008 | Not classified | Z-1820-2008 | Error in labeling | This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning… |
| Nov 7, 2007 | Not classified | Z-2064-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2072-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2071-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2061-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2063-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2069-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2067-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2065-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2062-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2073-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2066-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2076-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2075-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2068-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2074-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2078-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2060-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2077-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
| Nov 7, 2007 | Not classified | Z-2070-2008 | Device Design | This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking… |
The 5 latest of 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K110679 (Phygen, LLC, 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K050060.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TM Monoaxial Pedicle Screw System is intended for 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/K051275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051275: Laguna Monoaxial Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051275
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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