510(k) · Cleared
ClearedModification to Isola Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 13, 2002 as substantially equivalent to K980485 (Acromed Corp., 1998) after a 29-day review. Its family tree reaches back 1 generation to 1998. 1 of the 405 devices in its family, counting itself, has a Class I recall. 403 later devices descend from it.
- Decided
- Aug 13, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980485 (1998). 403 later devices descend from it, 7 citing it directly. 1 of the 405 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK980485 Isola Spinal SystemAcromed Corp. · 1998
- This deviceK022285 Modification to Isola Spinal SystemDepuyacromed · 2002
- Descendant · cites it directly · 304 of its ownK073126 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 2 generations on · 269 of its ownK082195 Modifications to Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 3 generations on · 263 of its ownK092473 Expedium Spine SystemDepuy Spine, Inc. · 2009
- Descendant · 4 generations on · 260 of its ownK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- Descendant · 5 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
Showing 5 of 403 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 403 · See all- K073126Expedium Spine SystemDepuy Spine, Inc. · 2007 · cites it directly304descendants
- K082195Modifications to Expedium Spine SystemDepuy Spine, Inc. · 2008 · 2 generations on269descendants
- K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · 3 generations on263descendants
- K101070Expedium Spine SystemMedos International SARL · 2010 · 4 generations on260descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 5 generations on225descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980485 | Isola Spinal System | Acromed Corp. | 1998 | — |
| 0 (this device) | K022285 | Modification to Isola Spinal System | Depuyacromed | 2002 | — |
| +1 | K073126 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +2 | K082195 | Modifications to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +3 | K092473 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +4 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| +5 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 10 | 0 |
| 2013 | 15 | 0 |
| 2014 | 16 | 0 |
| 2015 | 22 | 0 |
| 2016 | 16 | 0 |
| 2017 | 22 | 0 |
| 2018 | 21 | 0 |
| 2019 | 23 | 0 |
| 2020 | 28 | 0 |
| 2021 | 21 | 1 |
| 2022 | 30 | 0 |
| 2023 | 44 | 0 |
| 2024 | 47 | 0 |
| 2025 | 43 | 0 |
| 2026 | 34 | 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? (1)
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 |
|---|---|---|---|
| * | K980485 | Isola Spinal SystemSummary page 1…nterlaminal Orthosis, Spinal Pedicle Fixation PROPRl ETARY NAME: ISOLA Spinal System PREDICATE DEVICES: ISOLA Spinal System (K980485) DEVICE DESCRIPTION: The additional ISOLA Spinal components are connectors, open and closed… | 1998 |
What descends from it? (403)
See all 4037 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073126 | Expedium Spine System | 2007 | 304 |
| K120291 | OP Spine System | 2012 | 138 |
| K133746 | Polaris Spinal System | 2014 | 67 |
| K081978 | Reliance Spinal Screw System | 2009 | 8 |
| K101112 | Reliance Spinal Screw System | 2010 | 7 |
| K110896 | Reliance Spinal Screw System | 2012 | 5 |
| 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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 ISOLA Spinal 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 Spinal 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 Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-SI 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 Spinal System is also a hook and sacralliliac 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 as stated in the FDA summary.
https://510kreport.com/device/K022285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022285: Modification to Isola Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022285
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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