510(k) · Cleared
ClearedExpedium Mis Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 8, 2004 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) and 2 other predicates after a 68-day review. Its family tree reaches back 1 generation to 2003. 533 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 68 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K032265 (2003). 3 ancestors in all. 533 later devices descend from it, 12 citing it directly.
- Root · 1 generation backK032265 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2003
- This deviceK041801 Expedium Mis Spine SystemDepuy Spine, Inc. · 2004
- Descendant · cites it directly · 517 of its ownK061520 Viper Spine SystemDepuy Spine, Inc. · 2006
- Descendant · cites it directly · 423 of its ownK071860 Modification to: Viper Spine SystemDepuy Spine, Inc. · 2007
- Descendant · cites it directly · 337 of its ownK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- Descendant · cites it directly · 248 of its ownK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 2 generations on · 218 of its ownK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
Showing 5 of 533 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 533 · See all- K061520Viper Spine SystemDepuy Spine, Inc. · 2006 · cites it directly517descendants
- K071860Modification to: Viper Spine SystemDepuy Spine, Inc. · 2007 · cites it directly423descendants
- K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · cites it directly337descendants
- K070387Expedium Spine SystemDepuy Spine, Inc. · 2007 · cites it directly248descendants
- K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010 · 2 generations on218descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032265 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2003 | — |
| 0 (this device) | K041801 | Expedium Mis Spine System | Depuy Spine, Inc. | 2004 | — |
| +1 | K061520 | Viper Spine System | Depuy Spine, Inc. | 2006 | — |
| +1 | K071860 | Modification to: Viper Spine System | Depuy Spine, Inc. | 2007 | — |
| +1 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| +1 | K070387 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +2 | K102249 | Expedium Spine System | Depuy Spine, A Johnson & Johnson Company | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 9 | 0 |
| 2011 | 14 | 0 |
| 2012 | 28 | 0 |
| 2013 | 22 | 0 |
| 2014 | 23 | 0 |
| 2015 | 31 | 0 |
| 2016 | 24 | 0 |
| 2017 | 33 | 0 |
| 2018 | 30 | 0 |
| 2019 | 31 | 0 |
| 2020 | 32 | 0 |
| 2021 | 22 | 0 |
| 2022 | 33 | 0 |
| 2023 | 53 | 0 |
| 2024 | 48 | 0 |
| 2025 | 43 | 0 |
| 2026 | 42 | 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…amninal Orthosis, Spinal Pedicle Fixation PROPRIETARY NAME: ExpediuM TM MIS Spine System PREDICATE DEVICES: ExpediUM TM Spine System (K033901), CD Horizon® Spinal System (K032033 and K032265) DEVICE DESCRIPTION: The Expedium MIS System consists o… | 2004 |
| * | K032033 | CD Horizon Spinal SystemSummary page 1…PROPRIETARY NAME: ExpediuM TM MIS Spine System PREDICATE DEVICES: ExpediUM TM Spine System (K033901), CD Horizon® Spinal System (K032033 and K032265) DEVICE DESCRIPTION: The Expedium MIS System consists of cannulated polyaxial pedicle screws and… | 2003 |
| * | K032265 | CD Horizon Spinal SystemSummary page 1…Y NAME: ExpediuM TM MIS Spine System PREDICATE DEVICES: ExpediUM TM Spine System (K033901), CD Horizon® Spinal System (K032033 and K032265) DEVICE DESCRIPTION: The Expedium MIS System consists of cannulated polyaxial pedicle screws and 5.5mm rods i… | 2003 |
What descends from it? (533)
See all 53312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061520 | Viper Spine System | 2006 | 517 |
| K071860 | Modification to: Viper Spine System | 2007 | 423 |
| K090648 | Viper 2 System | 2009 | 337 |
| K070387 | Expedium Spine System | 2007 | 248 |
| K073562 | Modification to Viper Spine System | 2008 | 213 |
| K112643 | Focus Mis System | 2012 | 26 |
| K100757 | Tilock Pedicle Screw System | 2010 | 9 |
| K180337 | EUROPA Pedicle Screw System | 2019 | 6 |
| K110842 | Atlas Spine Pedicle Screw System | 2011 | 4 |
| K182970 | EUROPA™ Pedicle Screw System | 2019 | 2 |
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 NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Expedium MIS Spine System is intended for noncervical pedicle fixation and nonpedicle 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; pseudoarthrosis; and failed previous…
Read the full statement (137 words)
The Expedium MIS Spine System is intended for noncervical pedicle fixation and nonpedicle 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous, posterior approach with MIS Instrumentation, the Expedium MIS System screw components are intended for noncervical pedicle fixation and nonpedicle 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041801: Expedium Mis Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041801
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