510(k) · Cleared
ClearedIss Integrated Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 26, 2006 after a 116-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 26, 2006
- Review
- 116 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
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 | — |
What is it indicated for?
The Integrated Spine System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-SI vertebral joint in skeletally mature patients receiving fusion b.utogenonrhrof4~aa.hav/ng implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion mass. Use of a rod and ileo-sacral screw fixation system, TI-S1, the lumbar screws and rods will assist in arthrodesis…
Read the full statement (124 words)
The Integrated Spine System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-SI vertebral joint in skeletally mature patients receiving fusion b.utogenonrhrof4~aa.hav/ng implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion mass.
Use of a rod and ileo-sacral screw fixation system, TI-S1, the lumbar screws and rods will assist in arthrodesis or fusion of the lumbar spine. The indications for use are:
1. Spondylolisthesis
2. Spinal Fractures
3. Spinal Stenosis
4. Deformities (Idiopathic Scoliosis, Adult Kyphosis, Lordosis)
5. Pseudarthrosis of previous fusion
6. Instability caused by Trauma or Tumors
7. Revision of previously failed fusion surgery
8. Degenerative Disk Disease
9. Stabilization after Osteotomy
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061524: Iss Integrated Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061524
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026