510(k) · Cleared
ClearedIsola Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acromed Corp. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 21, 1998 after a 254-day review. The FDA summary names its predicate without a number. 1 of the 644 devices in its family, counting itself, has a Class I recall. 643 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 254 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
643 later devices descend from it, 14 citing it directly. 1 of the 644 devices in this family, counting this one, has a Class I recall.
- This deviceK980485 Isola Spinal SystemAcromed Corp. · 1998
- Descendant · cites it directly · 596 of its ownK010576 Monarch Spine SystemDepuyacromed · 2001
- Descendant · 2 generations on · 578 of its ownK024348 Monarch Spine SystemDepuyacromed · 2003
- Descendant · 2 generations on · 496 of its ownK021148 Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002
- Descendant · 3 generations on · 495 of its ownK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
- Descendant · 2 generations on · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
Showing 5 of 643 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 643 · See all- K010576Monarch Spine SystemDepuyacromed · 2001 · cites it directly596descendants
- K024348Monarch Spine SystemDepuyacromed · 2003 · 2 generations on578descendants
- K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002 · 2 generations on496descendants
- K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005 · 3 generations on495descendants
- K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on490descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980485 | Isola Spinal System | Acromed Corp. | 1998 | — |
| +1 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| +2 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| +2 | K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | Depuyacromed | 2002 | — |
| +3 | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | Depuy Spine, Inc. | 2005 | — |
| +2 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 28 | 0 |
| 2013 | 28 | 0 |
| 2014 | 28 | 0 |
| 2015 | 34 | 0 |
| 2016 | 31 | 0 |
| 2017 | 36 | 0 |
| 2018 | 46 | 0 |
| 2019 | 36 | 0 |
| 2020 | 39 | 0 |
| 2021 | 31 | 1 |
| 2022 | 39 | 0 |
| 2023 | 58 | 0 |
| 2024 | 55 | 0 |
| 2025 | 51 | 0 |
| 2026 | 48 | 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.
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? (2)
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 |
|---|---|---|---|
| * | — | Townley Screw Named without a submission number | |
| * | — | CD Spinal System Named without a submission number |
What descends from it? (643)
See all 64314 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K010576 | Monarch Spine System | 2001 | 596 |
| K022285 | Modification to Isola Spinal System | 2002 | 403 |
| K063772 | Expedium Spine System | 2007 | 264 |
| K101070 | Expedium Spine System | 2010 | 260 |
| K102249 | Expedium Spine System | 2010 | 218 |
| K120291 | OP Spine System | 2012 | 138 |
| K042928 | Modification to Global Spinal Fixation System | 2005 | 124 |
| K013440 | Isobar Spinal System | 2001 | 84 |
| K992738 | Isobar Spinal System | 1999 | 63 |
| K013447 | Isobar Spinal System | 2002 | 38 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K010576 (Depuyacromed, 2001) has gone furthest, with 596 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4)…
Read the full statement (339 words)
The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The Posterior ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacralfiliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion surgery.
The Anterior ISOLA system is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.
The Anterior ISOLA system is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:
1. Collapsing and unstable paralytic deformity.
2. Progressively increasing scoliosis.
3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
4. Inability to maintain sitting balance, necessitating the use of the hands.
5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
6. Spinal fractures (acute reduction or late deformity)
7. Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
8. Spinal tumor
9. Previous failed fusion surgery.
Spinal levels for Anterior ISOLA instrumentation are from T5-L4.
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/K980485 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980485: Isola Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980485
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026