510(k) · Cleared
ClearedRevolution Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Innovations, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Dec 19, 2003 after a 151-day review. The FDA summary names its predicate without a number. 98 later devices descend from it.
- Decided
- Dec 19, 2003
- Review
- 151 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
98 later devices descend from it, 9 citing it directly.
- This deviceK032219 Revolution Spinal Fixation SystemSpinal Innovations, Inc. · 2003
- Descendant · cites it directly · 95 of its ownK071945 S4 Spinal SystemAesculap Implant Systems · 2007
- Descendant · cites it directly · 95 of its ownK062085 S4 Spinal SystemAesculap · 2007
- Descendant · cites it directly · 94 of its ownK090657 Modification to: S4 Spinal SystemAesculap Implant Systems · 2009
- Descendant · cites it directly · 92 of its ownK100623 Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · Recalled
- Descendant · cites it directly · 61 of its ownK112551 S4 Spinal SystemAesculap Implant System, Inc. · 2011
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K071945S4 Spinal SystemAesculap Implant Systems · 2007 · cites it directly95descendants
- K062085S4 Spinal SystemAesculap · 2007 · cites it directly95descendants
- K090657Modification to: S4 Spinal SystemAesculap Implant Systems · 2009 · cites it directly94descendants
- K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · cites it directly92descendants
- K112551S4 Spinal SystemAesculap Implant System, Inc. · 2011 · cites it directly61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032219 | Revolution Spinal Fixation System | Spinal Innovations, Inc. | 2003 | — |
| +1 | K071945 | S4 Spinal System | Aesculap Implant Systems | 2007 | — |
| +1 | K062085 | S4 Spinal System | Aesculap | 2007 | — |
| +1 | K090657 | Modification to: S4 Spinal System | Aesculap Implant Systems | 2009 | — |
| +1 | K100623 | Aesculap Implant Systems S4 Spinal System | Aesculap Implant Systems | 2010 | 1 |
| +1 | K112551 | S4 Spinal System | Aesculap Implant System, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 14 | 0 |
| 2024 | 12 | 0 |
| 2025 | 10 | 0 |
| 2026 | 6 | 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 MNI? 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? (5)
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 |
|---|---|---|---|
| * | — | Silhouette Spinal System by Centerpulse Spine-Tech Named without a submission number | |
| * | — | CD Horizon Multi Axial Screw System by Sofamor Danek, Inc. Named without a submission number | |
| * | — | TSRH Spinal Implant System by Sofamor Danek, Inc. Named without a submission number | |
| * | — | MOSS Miami System by DePuy Motech, Inc. Named without a submission number | |
| * | — | Ascend Spinal System with the Shadow Spinal System by Spinal Innovations, Inc. Named without a submission number |
What descends from it? (98)
See all 989 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071945 | S4 Spinal System | 2007 | 95 |
| K062085 | S4 Spinal System | 2007 | 95 |
| K090657 | Modification to: S4 Spinal System | 2009 | 94 |
| K100623 | Aesculap Implant Systems S4 Spinal System | 2010 | 92 |
| K112551 | S4 Spinal System | 2011 | 61 |
| K121670 | Medyssey Cannulated Pedicle Screw | 2013 | 11 |
| K123939 | S4 Spinal System | 2013 | 3 |
| K162134 | ENNOVATE Spinal System | 2016 | 2 |
| K083004 | Mili (Minimally Invasive Lumbar Implant) System | 2009 | 0 |
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?
- Of its descendants, K071945 (Aesculap Implant Systems, 2007) has gone furthest, with 95 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 Spinal Innovations REVOLUTION TM Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S 1joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this…
Read the full statement (315 words)
The Spinal Innovations REVOLUTION TM Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S 1joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S 1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
The Spinal Innovations REVOLUTION TM Spinal Fixation 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).
When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations REVOLUTION TM Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations REVOLUTION TM Spinal Fixation System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are TI to the sacrum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032219: Revolution Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032219
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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