510(k) · Cleared
ClearedVSP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Motech Acromed · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jan 20, 1999 after a 47-day review. The FDA summary names its predicate without a number. 1 of the 309 devices in its family, counting itself, has a Class I recall. 308 later devices descend from it.
- Decided
- Jan 20, 1999
- Review
- 47 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
308 later devices descend from it, 6 citing it directly. 1 of the 309 devices in this family, counting this one, has a Class I recall.
- This deviceK984350 VSP SystemDepuy Motech Acromed · 1999
- Descendant · cites it directly · 260 of its ownK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- Descendant · 2 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · 3 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 4 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- Descendant · 3 generations on · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
Showing 5 of 308 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 308 · See all- K101070Expedium Spine SystemMedos International SARL · 2010 · cites it directly260descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on225descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 3 generations on172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 4 generations on158descendants
- K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · 3 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984350 | VSP System | Depuy Motech Acromed | 1999 | — |
| +1 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| +2 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| +3 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +4 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| +3 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 13 | 0 |
| 2018 | 17 | 0 |
| 2019 | 18 | 0 |
| 2020 | 26 | 0 |
| 2021 | 17 | 1 |
| 2022 | 24 | 0 |
| 2023 | 37 | 0 |
| 2024 | 43 | 0 |
| 2025 | 37 | 0 |
| 2026 | 33 | 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 |
|---|---|---|---|
| * | — | VSP System Named without a submission number |
What descends from it? (308)
See all 3086 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101070 | Expedium Spine System | 2010 | 260 |
| K990721 | Isolock Spinal System | 1999 | 64 |
| K001080 | Spine System Evolution | 2000 | 62 |
| K100757 | Tilock Pedicle Screw System | 2010 | 9 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
| K993551 | Socon Spinal System | 2000 | 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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K101070 (Medos International SARL, 2010) has gone furthest, with 260 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 VSP System is indicated for degenerative spondylolisthesis, in skeletally mature N patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, limbar and sacral spine.
The VSP Systern is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at LS-31, 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.
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/K984350 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984350: VSP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984350
Report an extraction error
Are you the manufacturer?
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