510(k) · Cleared
ClearedModification to: Viper 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 Aug 1, 2007 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) and 2 other predicates after a 27-day review. Its family tree reaches back 3 generations to 2003. 423 later devices descend from it.
- Decided
- Aug 1, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K032265 (2003). 5 ancestors in all. 423 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK032265 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2003
- 2 generations backK041801 Expedium Mis Spine SystemDepuy Spine, Inc. · 2004
- 1 generation backK061520 Viper Spine SystemDepuy Spine, Inc. · 2006
- This deviceK071860 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 · 213 of its ownK073562 Modification to Viper Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 203 of its ownK111571 Viper SystemsJohnson & Johnson · 2011
- Descendant · 2 generations on · 184 of its ownK102701 Viper Spine SystemDepuy Spine, Inc. · 2010
- Descendant · 2 generations on · 162 of its ownK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
Showing 5 of 423 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 423 · See all- K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · cites it directly337descendants
- K073562Modification to Viper Spine SystemDepuy Spine, Inc. · 2008 · cites it directly213descendants
- K111571Viper SystemsJohnson & Johnson · 2011 · 2 generations on203descendants
- K102701Viper Spine SystemDepuy Spine, Inc. · 2010 · 2 generations on184descendants
- K101993Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · 2 generations on162descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032265 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −2 | K041801 | Expedium Mis Spine System | Depuy Spine, Inc. | 2004 | — |
| −1 | K061520 | Viper Spine System | Depuy Spine, Inc. | 2006 | — |
| 0 (this device) | K071860 | Modification to: Viper Spine System | Depuy Spine, Inc. | 2007 | — |
| +1 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| +1 | K073562 | Modification to Viper Spine System | Depuy Spine, Inc. | 2008 | — |
| +2 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| +2 | K102701 | Viper Spine System | Depuy Spine, Inc. | 2010 | — |
| +2 | K101993 | Viper System, Expedium System | Depuy Spine, Inc. | 2010 | 8 |
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 |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 21 | 0 |
| 2013 | 18 | 0 |
| 2014 | 17 | 0 |
| 2015 | 22 | 0 |
| 2016 | 21 | 0 |
| 2017 | 21 | 0 |
| 2018 | 27 | 0 |
| 2019 | 22 | 0 |
| 2020 | 26 | 0 |
| 2021 | 21 | 0 |
| 2022 | 29 | 0 |
| 2023 | 45 | 0 |
| 2024 | 42 | 0 |
| 2025 | 36 | 0 |
| 2026 | 37 | 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…: 87 Product Code(s): NKB, MNH, MNI, KWP, KWQ Proprietary Name: VIPERTM Spine System Predicate Devices: EXPEDIUMTM 5.5mm Spine System (K033901) VIPERTM Spine System (K041801, K061520) Device Description: This submission addresses additi… | 2004 |
| * | K041801 | Expedium Mis Spine SystemSummary page 1…Proprietary Name: VIPERTM Spine System Predicate Devices: EXPEDIUMTM 5.5mm Spine System (K033901) VIPERTM Spine System (K041801, K061520) Device Description: This submission addresses additional rod components. Intended Use: The VIPER… | 2004 |
| * | K061520 | Viper Spine SystemSummary page 1…rietary Name: VIPERTM Spine System Predicate Devices: EXPEDIUMTM 5.5mm Spine System (K033901) VIPERTM Spine System (K041801, K061520) Device Description: This submission addresses additional rod components. Intended Use: The VIPER Spine Sy… | 2006 |
What descends from it? (423)
See all 4235 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090648 (Depuy Spine, Inc., 2009) has gone furthest, with 337 descendants of its own.
- 34 other devices also cite its predicate K033901.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. 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…
Read the full statement (173 words)
The VIPER Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
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 posterior percutaneous 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/K071860 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071860: Modification to: Viper 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/K071860
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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