510(k) · Cleared
ClearedViper 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 Jun 23, 2006 as substantially equivalent to K041801 (Depuy Spine, Inc., 2004) after a 21-day review. Its family tree reaches back 2 generations to 2003. 517 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032265 (2003). 4 ancestors in all. 517 later devices descend from it, 17 citing it directly.
- Root · 2 generations backK032265 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2003
- 1 generation backK041801 Expedium Mis Spine SystemDepuy Spine, Inc. · 2004
- This deviceK061520 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
- Descendant · 2 generations on · 213 of its ownK073562 Modification to Viper Spine SystemDepuy Spine, Inc. · 2008
Showing 5 of 517 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 517 · See all- 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
- K073562Modification to Viper Spine SystemDepuy Spine, Inc. · 2008 · 2 generations on213descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032265 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −1 | K041801 | Expedium Mis Spine System | Depuy Spine, Inc. | 2004 | — |
| 0 (this device) | 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 | — |
| +2 | K073562 | Modification to Viper Spine System | Depuy Spine, Inc. | 2008 | — |
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 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 11 | 0 |
| 2012 | 27 | 0 |
| 2013 | 22 | 0 |
| 2014 | 23 | 0 |
| 2015 | 30 | 0 |
| 2016 | 23 | 0 |
| 2017 | 33 | 0 |
| 2018 | 30 | 0 |
| 2019 | 27 | 0 |
| 2020 | 32 | 0 |
| 2021 | 22 | 0 |
| 2022 | 33 | 0 |
| 2023 | 53 | 0 |
| 2024 | 47 | 0 |
| 2025 | 42 | 0 |
| 2026 | 41 | 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? (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 |
|---|---|---|---|
| * | K041801 | Expedium Mis Spine SystemSummary page 1…nterlaminal Orthosis, Spinal Pedicle Fixation PROPRIETARY NAME: VIPER TM Spine System PREDICATE DEVICES: ExpediumTM MIS Spine System (K041801) DEVICE DESCRIPTION: The VIPER Spine System consists of cannulated polyaxial pedicle screws and 5.5mm rods in… | 2004 |
What descends from it? (517)
See all 51717 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071860 | Modification to: Viper Spine System | 2007 | 423 |
| K090648 | Viper 2 System | 2009 | 337 |
| K070387 | Expedium Spine System | 2007 | 248 |
| K061813 | Mantis Spinal System | 2006 | 135 |
| K112037 | Range Spinal System (Mesa and Denali) | 2011 | 65 |
| K121728 | Tiger Spine System | 2012 | 50 |
| K120696 | Tiger Spine System | 2012 | 41 |
| K121172 | Reform Pedicle Screw System | 2012 | 33 |
| K100605 | Mis System | 2010 | 33 |
| K131810 | Osseus Black Diamond Pedicle Screw System | 2013 | 14 |
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K071860 (Depuy Spine, Inc., 2007) has gone furthest, with 423 descendants of its own.
- 11 other devices also cite its predicate K041801.
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 VIPER 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…
Read the full statement (133 words)
The VIPER 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 VIPER 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061520: Viper Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061520
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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