510(k) · Cleared
ClearedViper Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 6, 2011 as substantially equivalent to K073562 (Depuy Spine, Inc., 2008) and 4 other predicates after a 30-day review. Its family tree reaches back 12 generations to 1985. 203 later devices descend from it.
- Decided
- Jul 6, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K853033 (1985). 84 ancestors in all, the oldest K841189 (1984). 203 later devices descend from it, 9 citing it directly.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK111571 Viper SystemsJohnson & Johnson · 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 · cites it directly · 50 of its ownK121728 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · 3 generations on · 48 of its ownK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 41 of its ownK120696 Tiger Spine SystemCorelink, LLC · 2012
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK111571 Viper SystemsJohnson & Johnson · 2011
Showing 5 of 203 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 203 · See all- 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
- K121728Tiger Spine SystemCorelink, LLC · 2012 · cites it directly50descendants
- K161014NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · 3 generations on48descendants
- K120696Tiger Spine SystemCorelink, LLC · 2012 · cites it directly41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −1 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K111571 | Viper Systems | Johnson & Johnson | 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 | — |
| +1 | K121728 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +3 | K161014 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 13 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 5 | 0 |
| 2013 | 10 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 9 | 0 |
| 2017 | 7 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 14 | 0 |
| 2021 | 9 | 0 |
| 2022 | 16 | 0 |
| 2023 | 25 | 0 |
| 2024 | 25 | 0 |
| 2025 | 21 | 0 |
| 2026 | 20 | 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? (5)
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 |
|---|---|---|---|
| * | K073562 | Modification to Viper Spine SystemSummary page 2…age I 5 -f. F. Predicate Device Name Trade name: DePuy Spine EXPEDI UM/VI PERO Spine System (K073562) DePuy Spine EXPEDIUM® Spine System (K070387) DePuy Spine EXPEDIUM® Spine System (K0803… | 2008 |
| * | K070387 | Expedium Spine SystemSummary page 2…age 2 === F. Predicate Device Name Trade name: DePuy Spine EXPEDI UM/VI PERO Spine System (K073562) DePuy Spine EXPEDIUM® Spine System (K070387) DePuy Spine EXPEDIUM® Spine System (K080313) DePuy Spine EXPEDIUM® Spine System (K1022… | 2007 |
| * | K080313 | Modification to Expedium Spine SystemSummary page 2…Spine EXPEDI UM/VI PERO Spine System (K073562) DePuy Spine EXPEDIUM® Spine System (K070387) DePuy Spine EXPEDIUM® Spine System (K080313) DePuy Spine EXPEDIUM® Spine System (K102249) DePuy Spine MOSS MIAMI Spine System (K011… | 2008 |
| * | K102249 | Expedium Spine SystemSummary page 2…DePuy Spine EXPEDIUM® Spine System (K070387) DePuy Spine EXPEDIUM® Spine System (K080313) DePuy Spine EXPEDIUM® Spine System (K102249) DePuy Spine MOSS MIAMI Spine System (K011182) 6. Device Description The VIPER Sys… | 2010 |
| * | K011182 | Modified Moss Miami 4.35MM Diameter Polyaxial ScrewsSummary page 2…DePuy Spine EXPEDIUM® Spine System (K080313) DePuy Spine EXPEDIUM® Spine System (K102249) DePuy Spine MOSS MIAMI Spine System (K011182) 6. Device Description The VIPER Systems are 5.5mm rod systems offered in both titanium and… | 2001 |
What descends from it? (203)
See all 2039 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121020 | Viper System | 2012 | 94 |
| K121728 | Tiger Spine System | 2012 | 50 |
| K120696 | Tiger Spine System | 2012 | 41 |
| K121016 | Range Spinal System (Mesa and Denali) | 2012 | 38 |
| K121172 | Reform Pedicle Screw System | 2012 | 33 |
| K131810 | Osseus Black Diamond Pedicle Screw System | 2013 | 14 |
| 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 26 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 84 ancestors have a recall of any class.
- Of its descendants, K121020 (Depuy Spine, Inc., 2012) has gone furthest, with 94 descendants of its own.
- 3 other devices also cite its predicate K073562.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Systems are intended to provide immobilization anid staliIization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute anid chronic instabilities or deformities of the thoracie. lumbar anid sacral spine. The VIPER Systems metallic components are intended for noncervical pediele fixation and nonprediele fixation for fusion for the following indications: degenerative disc disease (defined as back Pain…
Read the full statement (206 words)
The VIPER Systems are intended to provide immobilization anid staliIization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute anid chronic instabilities or deformities of the thoracie. lumbar anid sacral spine.
The VIPER Systems metallic components are intended for noncervical pediele fixation and nonprediele fixation for fusion for the following indications: degenerative disc disease (defined as back Pain of discogenic origin with degeneration ofthe disc confirmed by history and radiographic Studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal steniosis; curvatures (i.e., scoliosis, kyphosis, anid/or lordlosis); tumor, pseuidoarthrosis; anid failed previous fusion in skeletally mature patients.
When used in a posterior per-cutaneCous approach with MIS instrumnentation, the VIPER Systems metallic components ave intended for noncervical pedicle Fixation and nonpedicle Fixation for fusion 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, pseudlarthrosis; anid failed previous fusion in skeletally mature patients.
The VIPER PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from LI -Si in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111571: Viper Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111571
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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