510(k) · Cleared
Recalled · 2009Capless LI Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 14, 2007 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it. It has been recalled once.
- Decided
- Sep 14, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 1
- Predicates
- 0
17 later devices descend from it, 4 citing it directly.
- This deviceK072282 Capless LI Pedicle Screw SystemX-Spine Systems, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK081978 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009
- Descendant · cites it directly · 7 of its ownK101112 Reliance Spinal Screw SystemReliance Medical Systems · 2010
- Descendant · cites it directly · 7 of its ownK090224 Fortex Pedicle Screw SystemX-Spine Systems, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK123521 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
- Descendant · cites it directly · 5 of its ownK110896 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009 · cites it directly8descendants
- K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010 · cites it directly7descendants
- K090224Fortex Pedicle Screw SystemX-Spine Systems, Inc. · 2009 · cites it directly7descendants
- K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013 · 2 generations on5descendants
- K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072282 | Capless LI Pedicle Screw System | X-Spine Systems, Inc. | 2007 | — |
| +1 | K081978 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2009 | — |
| +1 | K101112 | Reliance Spinal Screw System | Reliance Medical Systems | 2010 | — |
| +1 | K090224 | Fortex Pedicle Screw System | X-Spine Systems, Inc. | 2009 | — |
| +2 | K123521 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2013 | — |
| +1 | K110896 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 MNH? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 174 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 |
|---|---|---|---|---|
| Mar 24, 2009 | Not classified | Z-1694-2009 | Process control | A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081978 (Reliance Medical Systems, LLC, 2009) has gone furthest, with 8 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K072282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072282: Capless LI 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/K072282
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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