510(k) Report

510(k) · Cleared

Cleared

Viper 2 System

K090648510(k) SpecialCleared Jun 10, 200991-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jun 10, 2009 as substantially equivalent to K082942 (Depuy Spine, Inc., 2008) and 9 other predicates after a 91-day review. Its family tree reaches back 6 generations to 1995. 337 later devices descend from it.

Decided
Jun 10, 2009
Review
91 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
10

Its longest line of descent runs back 6 generations to K950697 (1995). 35 ancestors in all, the oldest K933881 (1994). 337 later devices descend from it, 20 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2007: 3 other ancestors2006: 2 other ancestors2004: 6 other ancestors1998: 1 other ancestor1997: 1 other ancestor1994: 1 other ancestor2005: 2 other ancestors2003: 4 other ancestors2001: 3 other ancestors2002: 1 other ancestor1999: 1 other ancestor1996: 1 other ancestor2000: 1 other ancestor2015: 13 descendants cleared2016: 13 descendants cleared2014: 8 descendants cleared2011: 4 descendants cleared2010: 3 descendants cleared2012: 12 descendants cleared2024: 40 descendants cleared2013: 8 descendants cleared2019: 20 descendants cleared2017: 20 descendants cleared2020: 23 descendants cleared2018: 21 descendants cleared2025: 34 descendants cleared2023: 40 descendants cleared2021: 17 descendants cleared2022: 25 descendants cleared2026: 36 descendants clearedK950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995×2: 2 generations cleared close together, K050461 (2005), K052761 (2005) ×2: 2 generations cleared close together, K060361 (2006), K060979 (2006) K082942 · Modfication to: Expedium Spine System · Depuy Spine, Inc. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 7 other ancestors3 generations back: 8 other ancestors4 generations back: 1 other ancestor5 generations back: 3 other ancestors6 generations back: 1 other ancestor 1 generation forward: 20 descendants2 generations forward: 33 descendants3 generations forward: 53 descendants4 generations forward: 70 descendants5 generations forward: 55 descendants6 generations forward: 45 descendants7 generations forward: 23 descendants8 generations forward: 21 descendants9 generations forward: 17 descendants K082942 · Modfication to: Expedium Spine System · Depuy Spine, Inc. · 2008K060979 · Xia Titanium and 4.5 Spinal Systems · Stryker Spine · 2006K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalledK052761 · Modification to: Xia 4.5 Spinal System · Stryker Spine · 2005K050461 · Xia 4.5 Spinal System · Stryker Spine · 2005K950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995−50+5
  1. Root · 6 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. 5 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. 4 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. 3 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. 2 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
  6. 1 generation backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
  7. This deviceK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
  8. Descendant · cites it directly · 184 of its ownK102701 Viper Spine SystemDepuy Spine, Inc. · 2010
  9. Descendant · cites it directly · 162 of its ownK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
  10. Descendant · 2 generations on · 139 of its ownK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
  11. Descendant · cites it directly · 103 of its ownK110906 Apex Spine SystemSpinecraft, LLC · 2011
  12. Descendant · 2 generations on · 94 of its ownK121020 Viper SystemDepuy Spine, Inc. · 2012

Showing 5 of 337 descendants. See all descendants

Descendants cleared per year

2010: 32011: 42012: 122013: 82014: 82015: 132016: 132017: 202018: 212019: 202020: 232021: 172022: 252023: 402024: 402025: 342026: 36
2010high 40 (2023) · low 3 (2010)2026

Most influential descendants

Showing 5 of 337 · See all
  • K102701Viper Spine SystemDepuy Spine, Inc. · 2010 · cites it directly184descendants
  • K101993Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · cites it directly162descendants
  • K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013 · 2 generations on139descendants
  • K110906Apex Spine SystemSpinecraft, LLC · 2011 · cites it directly103descendants
  • K121020Viper SystemDepuy Spine, Inc. · 2012 · 2 generations on94descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
−5K050461Xia 4.5 Spinal SystemStryker Spine2005—
−4K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
−3K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
−2K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006—
−1K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008—
0 (this device)K090648Viper 2 SystemDepuy Spine, Inc.2009—
+1K102701Viper Spine SystemDepuy Spine, Inc.2010—
+1K101993Viper System, Expedium SystemDepuy Spine, Inc.20108
+2K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013—
+1K110906Apex Spine SystemSpinecraft, LLC2011—
+2K121020Viper SystemDepuy Spine, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199610
199710
199810
199910
200010
200130
200210
200340
200460
200520
200620
200730
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201140
2012120
201380
201480
2015130
2016130
2017200
2018210
2019200
2020230
2021170
2022250
2023400
2024400
2025340
2026360
FIG. 1 — Lineage of K090648, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K082942Modfication to: Expedium Spine System
Summary page 1
…Panel Number: 87 Product Code(s): NKB, KWQ, KWP, MNH, MNI Proprietary Name: VIPERTM2 System Predicate Devices: EXPEDIUM TM Spine System (K082942, K033901, K041119, K073364) VIPER System (K071860, K061520, K041801)…
Depuy Spine, Inc.2008—
*K033901Merlin Spine System
Summary page 1
…ber: 87 Product Code(s): NKB, KWQ, KWP, MNH, MNI Proprietary Name: VIPERTM2 System Predicate Devices: EXPEDIUM TM Spine System (K082942, K033901, K041119, K073364) VIPER System (K071860, K061520, K041801)…
Depuy Spine, Inc.2004—
*K041119Expedium Spine System
Summary page 1
…NKB, KWQ, KWP, MNH, MNI Proprietary Name: VIPERTM2 System Predicate Devices: EXPEDIUM TM Spine System (K082942, K033901, K041119, K073364) VIPER System (K071860, K061520, K041801) MOSS MIAMI Spine Syste…
Depuy Spine, Inc.2004—
*K073364Expedium 4.5MM Spine System
Summary page 1
…KWP, MNH, MNI Proprietary Name: VIPERTM2 System Predicate Devices: EXPEDIUM TM Spine System (K082942, K033901, K041119, K073364) VIPER System (K071860, K061520, K041801) MOSS MIAMI Spine System (K93388…
Depuy Spine, Inc.2008—
*K071860Modification to: Viper Spine System
Summary page 1
…2 System Predicate Devices: EXPEDIUM TM Spine System (K082942, K033901, K041119, K073364) VIPER System (K071860, K061520, K041801) MOSS MIAMI Spine System (K933881, K962628, K983583)…
Depuy Spine, Inc.2007—
*K061520Viper Spine System
Summary page 1
…Predicate Devices: EXPEDIUM TM Spine System (K082942, K033901, K041119, K073364) VIPER System (K071860, K061520, K041801) MOSS MIAMI Spine System (K933881, K962628, K983583) Devi…
Depuy Spine, Inc.2006—
*K041801Expedium Mis Spine System
Summary page 1
…edicate Devices: EXPEDIUM TM Spine System (K082942, K033901, K041119, K073364) VIPER System (K071860, K061520, K041801) MOSS MIAMI Spine System (K933881, K962628, K983583) Device Descri…
Depuy Spine, Inc.2004—
*K933881Depuy Motech Moss-Miami Spinal System
Summary page 1
…, K041119, K073364) VIPER System (K071860, K061520, K041801) MOSS MIAMI Spine System (K933881, K962628, K983583) Device Description: The subject VIPER2 Spine System components consist of…
Depuy, Inc.1994—
*K962628Moss Miami Spinal System
Summary page 1
…K041119, K073364) VIPER System (K071860, K061520, K041801) MOSS MIAMI Spine System (K933881, K962628, K983583) Device Description: The subject VIPER2 Spine System components consist of…
Depuy, Inc.1997—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 1
…) VIPER System (K071860, K061520, K041801) MOSS MIAMI Spine System (K933881, K962628, K983583) Device Description: The subject VIPER2 Spine System components consist of 5.5mm screws and rods…
Depuy, Inc.1998—

Also cleared against K082942: 6 other devices →

What descends from it? (337)

See all 337

20 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102701Viper Spine SystemDepuy Spine, Inc.2010184
K101993Viper System, Expedium SystemDepuy Spine, Inc.2010162
K110906Apex Spine SystemSpinecraft, LLC2011103
K113044Synthes MirsSynthes Spine201193
K133369Tiger Spine SystemCorelink, LLC201429
K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226
K132603Apex Spine SystemSpinecraft, LLC201325
K150417Astra Spine SystemSpinecraft, LLC201521
K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514
K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314

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 14 years and passes through 3 companies; a new generation was cleared every 7 months on median.
  • 2 of the 35 ancestors have a recall of any class.
  • Of its descendants, K102701 (Depuy Spine, Inc., 2010) has gone furthest, with 184 descendants of its own.
  • 6 other devices also cite its predicate K082942.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The VIPER Systems are 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 Systems are 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 (186 words)

The VIPER Systems are 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 Systems 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; 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 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.

The PEEK rods of EXPED1UM Spine System and VIPER Systems are contraindicated for degenerative disc disease.

Indications for use as stated in the FDA summary.

Also cleared against K082942

6 other devices cite the same predicate.

  • K180337EUROPA Pedicle Screw SystemMiRus, LLC · 2019
  • K182970EUROPA™ Pedicle Screw SystemMiRus, LLC · 2019
  • K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
  • K130877Expedium Spine SystemMedos International SARL · 2013
  • K0910675.5 Polaris Spinal SystemBiomet Spine · 2009
  • K090230Expedium Spine SystemDepuy Spine, Inc. · 2009

More from Depuy Spine, Inc.

86 FDA decisions under this applicant name. See the company

  • K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
  • K142185Expedium Verse Spine SystemDepuy Spine, Inc. · 2014
  • K111136Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 20121 recall
  • K121020Viper SystemDepuy Spine, Inc. · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K090648 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090648: Viper 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090648

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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