510(k) · Cleared
ClearedExpedium Spine System Spinous Process Fusion Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Apr 11, 2005 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) after a 26-day review. Its family tree reaches back 1 generation to 2004. 9 later devices descend from it.
- Decided
- Apr 11, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033901 (2004). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK033901 Merlin Spine SystemDepuy Spine, Inc. · 2004
- This deviceK050675 Expedium Spine System Spinous Process Fusion PlateDepuy Spine, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK102020 Vega Span Spinous Process Plate SystemSpinefrontier, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK213266 Inspan ScrewLES Fusion SystemLespine Innovations, LLC · 2021
- Descendant · 2 generations on · 3 of its ownK121316 Lanx Spinal Fization SystemLanx, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK131156 Lanx Spinal Fixation SystemLanx, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK232605 Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES…Lesspine Innovations · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K102020Vega Span Spinous Process Plate SystemSpinefrontier, Inc. · 2010 · cites it directly8descendants
- K213266Inspan ScrewLES Fusion SystemLespine Innovations, LLC · 2021 · 2 generations on3descendants
- K121316Lanx Spinal Fization SystemLanx, Inc. · 2012 · 2 generations on3descendants
- K131156Lanx Spinal Fixation SystemLanx, Inc. · 2013 · 3 generations on1descendant
- K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033901 | Merlin Spine System | Depuy Spine, Inc. | 2004 | — |
| 0 (this device) | K050675 | Expedium Spine System Spinous Process Fusion Plate | Depuy Spine, Inc. | 2005 | — |
| +1 | K102020 | Vega Span Spinous Process Plate System | Spinefrontier, Inc. | 2010 | — |
| +2 | K213266 | Inspan ScrewLES Fusion System | Lespine Innovations, LLC | 2021 | — |
| +2 | K121316 | Lanx Spinal Fization System | Lanx, Inc. | 2012 | — |
| +3 | K131156 | Lanx Spinal Fixation System | Lanx, Inc. | 2013 | — |
| +3 | K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System… | Lesspine Innovations | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K033901 | Merlin Spine SystemSummary page 1…bral Body Fixation PROPRIETARY NAME: EXPEDIUM Spine System Spinous Process Fusion Plates PREDICATE DEVICES: EXPEDIUM Spine System K033901 Wilson Spinal Plate DEVICE DESCRIPTION: The EXPEDIUM Spine System Spinous Process Fusion… | 2004 |
| * | — | Wilson Spinal Plate Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102020 | Vega Span Spinous Process Plate System | 2010 | 8 |
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 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 EXPEDIUM Spine System is intended for non-cervical, non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature…
Read the full statement (124 words)
The EXPEDIUM Spine System is intended for non-cervical, non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
The Expedium Spinous Process Fusion Plate is not intended for stand-alone use. When used with DePuy Spine VBR Spinal System components the Expedium Spinous Process Fusion Plate is intended for the following conditions:
* degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
* spondylolisthesis
* trauma (i.e., fracture or dislocation)
* tumor
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050675: Expedium Spine System Spinous Process Fusion Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050675
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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