510(k) · Cleared
ClearedIsola Spinal Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Oct 5, 2001 as substantially equivalent to K983583 (Depuy, Inc., 1998) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Oct 5, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K983583 (1998). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
- This deviceK012971 Isola Spinal SystemsDepuyacromed · 2001
- Descendant · cites it directly · 1 of its ownK021879 Crossover Cross Connector (Isola Spinal System)Depuyacromed · 2002
- Descendant · cites it directly · 0 of its ownK191212 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System…Medos International SARL · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983583 | Depuy Acromed Moss and Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| 0 (this device) | K012971 | Isola Spinal Systems | Depuyacromed | 2001 | — |
| +1 | K021879 | Crossover Cross Connector (Isola Spinal System) | Depuyacromed | 2002 | — |
| +1 | K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM… | Medos International SARL | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2019 | 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 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? (4)
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 |
|---|---|---|---|
| * | K983583 | Depuy Acromed Moss and Moss Miami Spinal SystemsSummary page 1…IETARY NAME: PREDICATE DEVICES: DEVICE DESCRIPTION: INTENDED USE: Orthosis, Spinal Pedicle Fixation ISOLA Spine System MOSS MIAMI Spinal System Transverse Connector (K983583) EZ-Link Transverse Connector (K001372, K001470) The CrossOver Cross Connector is designed to transversely connect two rods used… | 1998 |
| * | K001372 | E-Z Link Cross ConnectorSummary page 1…DESCRIPTION: INTENDED USE: Orthosis, Spinal Pedicle Fixation ISOLA Spine System MOSS MIAMI Spinal System Transverse Connector (K983583) EZ-Link Transverse Connector (K001372, K001470) The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs.… | 2000 |
| * | K001470 | E-Z Link Cross ConnectorSummary page 1…ION: INTENDED USE: Orthosis, Spinal Pedicle Fixation ISOLA Spine System MOSS MIAMI Spinal System Transverse Connector (K983583) EZ-Link Transverse Connector (K001372, K001470) The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The conne… | 2000 |
| * | — | ISOLA Spine System Named without a submission number |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 ISOLA Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed…
Read the full statement (222 words)
The ISOLA Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ISOLA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The ISOLA Spine System is also a hook and sacralfiliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012971: Isola Spinal Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012971
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026