510(k) · Cleared
ClearedIsola Open and Closed Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acromed Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on May 30, 1995 after a 246-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 492 devices in its family, counting itself, has a Class I recall. 491 later devices descend from it.
- Decided
- May 30, 1995
- Review
- 246 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
491 later devices descend from it, 2 citing it directly. 1 of the 492 devices in this family, counting this one, has a Class I recall.
- This deviceK944756 Isola Open and Closed ScrewsAcromed Corp. · 1995
- Descendant · cites it directly · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · 2 generations on · 424 of its ownK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · 2 generations on · 398 of its ownK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 2 generations on · 397 of its ownK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 264 of its ownK063772 Expedium Spine SystemDepuy Spine, Inc. · 2007
Showing 5 of 491 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 491 · See all- K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · cites it directly490descendants
- K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on424descendants
- K063741Expedium Spine SystemDepuy Spine, Inc. · 2007 · 2 generations on398descendants
- K080313Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008 · 2 generations on397descendants
- K063772Expedium Spine SystemDepuy Spine, Inc. · 2007 · 2 generations on264descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944756 | Isola Open and Closed Screws | Acromed Corp. | 1995 | — |
| +1 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +2 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +2 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +2 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +2 | K063772 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 15 | 0 |
| 2013 | 20 | 0 |
| 2014 | 19 | 0 |
| 2015 | 24 | 0 |
| 2016 | 18 | 0 |
| 2017 | 27 | 0 |
| 2018 | 33 | 0 |
| 2019 | 27 | 0 |
| 2020 | 30 | 0 |
| 2021 | 26 | 1 |
| 2022 | 35 | 0 |
| 2023 | 52 | 0 |
| 2024 | 52 | 0 |
| 2025 | 47 | 0 |
| 2026 | 41 | 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.
1 device in this family has a Class I recall. 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? (491)
See all 4912 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K062174 (Depuy Spine, Inc., 2006) has gone furthest, with 490 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.
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/K944756 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944756: Isola Open and Closed Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944756
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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