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 Oct 20, 2010 as substantially equivalent to K090648 (Depuy Spine, Inc., 2009) and 5 other predicates after a 30-day review. Its family tree reaches back 7 generations to 1995. 184 later devices descend from it.
- Decided
- Oct 20, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K950697 (1995). 38 ancestors in all, the oldest K933881 (1994). 184 later devices descend from it, 9 citing it directly.
- Root · 7 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 3 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 2 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- This deviceK102701 Viper Spine SystemDepuy Spine, Inc. · 2010
- Descendant · cites it directly · 103 of its ownK110906 Apex Spine SystemSpinecraft, LLC · 2011
- Descendant · cites it directly · 94 of its ownK121020 Viper SystemDepuy Spine, Inc. · 2012
- Descendant · 2 generations on · 84 of its ownK153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable…Medtronic Sofamor Danek USA, Inc. · 2016
- Descendant · 2 generations on · 81 of its ownK113058 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · 3 generations on · 48 of its ownK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
Showing 5 of 184 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 184 · See all- K110906Apex Spine SystemSpinecraft, LLC · 2011 · cites it directly103descendants
- K121020Viper SystemDepuy Spine, Inc. · 2012 · cites it directly94descendants
- K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc. · 2016 · 2 generations on84descendants
- K113058Tiger Spine SystemCorelink, LLC · 2012 · 2 generations on81descendants
- K161014NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · 3 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −6 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −3 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −2 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −1 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| 0 (this device) | K102701 | Viper Spine System | Depuy Spine, Inc. | 2010 | — |
| +1 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| +1 | K121020 | Viper System | Depuy Spine, Inc. | 2012 | — |
| +2 | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for… | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +2 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +3 | K161014 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 10 | 0 |
| 2019 | 13 | 0 |
| 2020 | 12 | 0 |
| 2021 | 9 | 0 |
| 2022 | 15 | 0 |
| 2023 | 23 | 0 |
| 2024 | 24 | 0 |
| 2025 | 24 | 0 |
| 2026 | 21 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090648 | Viper 2 SystemSummary page 1…cle screw spinal fixation per 21 CFR §888.3070 D. Predicate Device Name Trade name: DePuy Spine VIPER® Spine System (K090648) DePuy Spine EXPEDIUM® System (KO041119, K(033901, K(090230, K(071495) DePuy Spine Moss Miami… | 2009 |
| Kept off the family tree | K040119 | FDA’s K040119 is Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K033901 | Merlin Spine SystemSummary page 1…21 CFR §888.3070 D. Predicate Device Name Trade name: DePuy Spine VIPER® Spine System (K090648) DePuy Spine EXPEDIUM® System (KO041119, K(033901, K(090230, K(071495) DePuy Spine Moss Miami" System (K(011182, 1(953915) E. Device Description === Page 2… | 2004 |
| * | K090230 | Expedium Spine SystemSummary page 1…88.3070 D. Predicate Device Name Trade name: DePuy Spine VIPER® Spine System (K090648) DePuy Spine EXPEDIUM® System (KO041119, K(033901, K(090230, K(071495) DePuy Spine Moss Miami" System (K(011182, 1(953915) E. Device Description… | 2009 |
| * | K071495 | Expedium 4.5MM Spine SystemSummary page 1…D. Predicate Device Name Trade name: DePuy Spine VIPER® Spine System (K090648) DePuy Spine EXPEDIUM® System (KO041119, K(033901, K(090230, K(071495) DePuy Spine Moss Miami" System (K(011182, 1(953915) E. Device Description… | 2007 |
| * | K011182 | Modified Moss Miami 4.35MM Diameter Polyaxial ScrewsSummary page 1…VIPER® Spine System (K090648) DePuy Spine EXPEDIUM® System (KO041119, K(033901, K(090230, K(071495) DePuy Spine Moss Miami" System (K(011182, 1(953915) E. Device Description The VIPERS Systems consist of rods and cannulated strew… | 2001 |
| * | K953915 | Moss Miami Spinal System (Anterior Use)Summary page 1…ne System (K090648) DePuy Spine EXPEDIUM® System (KO041119, K(033901, K(090230, K(071495) DePuy Spine Moss Miami" System (K(011182, 1(953915) E. Device Description The VIPERS Systems consist of rods and cannulated strews used in… | 1996 |
What descends from it? (184)
See all 1849 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110906 | Apex Spine System | 2011 | 103 |
| K121020 | Viper System | 2012 | 94 |
| K132603 | Apex Spine System | 2013 | 25 |
| K150417 | Astra Spine System | 2015 | 21 |
| K131810 | Osseus Black Diamond Pedicle Screw System | 2013 | 14 |
| K143683 | APEX-DL Spine System | 2015 | 3 |
| K133575 | Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle… | 2014 | 3 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | 2016 | 2 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 2 of the 38 ancestors have a recall of any class.
- Of its descendants, K110906 (Spinecraft, LLC, 2011) has gone furthest, with 103 descendants of its own.
- 19 other devices also cite its predicate K090648.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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 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…
Read the full statement (170 words)
The VIPER 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 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 lordlosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedlicle fixation and nonpedlicle 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/K102701 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102701: Viper Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102701
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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