510(k) · Cleared
Recalled · 2008Laguna Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allez Spine, LLC · MNI Orthosis, Spinal Pedicle Fixation
Cleared on May 4, 2005 as substantially equivalent to K981676 (Sofamor Danek USA,Inc., 1999) after a 113-day review. Its family tree reaches back 1 generation to 1999. 21 later devices descend from it. It has been recalled 27 times.
- Decided
- May 4, 2005
- Review
- 113 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 27
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981676 (1999). 21 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- This deviceK050060 Laguna Pedicle Screw SystemAllez Spine, LLC · 2005
- Descendant · cites it directly · 16 of its ownK072678 Laguna Size 8 Pedicle ScrewAllez Spine, LLC · 2008
- 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
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
2005high 4 (2018) · low 0 (2006)2026
Most influential descendants
Showing 5 of 21 · See all- K072678Laguna Size 8 Pedicle ScrewAllez Spine, LLC · 2008 · cites it directly16descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| 0 (this device) | K050060 | Laguna Pedicle Screw System | Allez Spine, LLC | 2005 | — |
| +1 | K072678 | Laguna Size 8 Pedicle Screw | Allez Spine, LLC | 2008 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 4 | 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K981676 | CD Horizon Spinal SystemSummary page 1…the CD HORIZON Spinal System, which is manufactured and marketed by Medtronic Sofamore Danek K981676 S/E January 28, 1999 Indications: The Laguna Spinal System is intended for posterior, non-cervical fixation for… | 1999 |
What descends from it? (21)
See all 214 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 |
|---|---|---|---|---|
| Aug 21, 2008 | Not classified | Z-0153-2009 | 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-1819-2008 | 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… |
| Jul 30, 2007 | Not classified | Z-0190-2008 | Device Design | Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation. |
| Jul 30, 2007 | Not classified | Z-0189-2008 | Device Design | Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation. |
| Jul 30, 2007 | Not classified | Z-0191-2008 | Device Design | Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation. |
| Jul 30, 2007 | Not classified | Z-0186-2008 | Device Design | Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation. |
| Jul 30, 2007 | Not classified | Z-0187-2008 | Device Design | Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation. |
| Jul 30, 2007 | Not classified | Z-0188-2008 | Device Design | Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation. |
The 5 latest of 27 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2007high 23 (2008) · low 0 (2018)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
2007high 168 (2016) · low 54 (2015)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
2007high 26 (2007) · low 0 (2011)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
2007high 824 (2013) · low 80 (2025)2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Laguna Spinal 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/K050060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050060: Laguna 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/K050060
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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