510(k) · Cleared
ClearedIsola System
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 Jan 22, 1996 after a 255-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 703 devices in its family, counting itself, has a Class I recall. 702 later devices descend from it.
- Decided
- Jan 22, 1996
- Review
- 255 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
702 later devices descend from it, 5 citing it directly. 1 of the 703 devices in this family, counting this one, has a Class I recall.
- This deviceK952236 Isola SystemAcromed Corp. · 1996
- Descendant · cites it directly · 597 of its ownK981714 Timx Low Back System Titanium MX Rod Based Low Back SystemAcromed Corp. · 1998
- Descendant · 2 generations on · 596 of its ownK010576 Monarch Spine SystemDepuyacromed · 2001
- Descendant · 3 generations on · 578 of its ownK024348 Monarch Spine SystemDepuyacromed · 2003
- Descendant · 3 generations on · 496 of its ownK021148 Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002
- Descendant · 4 generations on · 495 of its ownK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
Showing 5 of 702 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 702 · See all- K981714Timx Low Back System Titanium MX Rod Based Low Back SystemAcromed Corp. · 1998 · cites it directly597descendants
- K010576Monarch Spine SystemDepuyacromed · 2001 · 2 generations on596descendants
- K024348Monarch Spine SystemDepuyacromed · 2003 · 3 generations on578descendants
- K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002 · 3 generations on496descendants
- K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005 · 4 generations on495descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952236 | Isola System | Acromed Corp. | 1996 | — |
| +1 | K981714 | Timx Low Back System Titanium MX Rod Based Low Back System | Acromed Corp. | 1998 | — |
| +2 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| +3 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| +3 | K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | Depuyacromed | 2002 | — |
| +4 | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | Depuy Spine, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 12 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 13 | 0 |
| 2011 | 9 | 0 |
| 2012 | 29 | 0 |
| 2013 | 33 | 0 |
| 2014 | 30 | 0 |
| 2015 | 40 | 0 |
| 2016 | 32 | 0 |
| 2017 | 42 | 0 |
| 2018 | 50 | 0 |
| 2019 | 36 | 0 |
| 2020 | 39 | 0 |
| 2021 | 32 | 1 |
| 2022 | 39 | 0 |
| 2023 | 61 | 0 |
| 2024 | 59 | 0 |
| 2025 | 53 | 0 |
| 2026 | 47 | 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? (702)
See all 7025 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981714 | Timx Low Back System Titanium MX Rod Based Low Back System | 1998 | 597 |
| K982511 | Depuy Motech Moss Miami Spinal Systems | 1998 | 413 |
| K063772 | Expedium Spine System | 2007 | 264 |
| K981113 | Pediatric PRC | 1998 | 1 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K981714 (Acromed Corp., 1998) has gone furthest, with 597 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/K952236 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952236: Isola System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952236
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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