510(k) Report

510(k) · Cleared

Cleared

Viper F2 Facet Fixation System

K101762510(k) SpecialCleared Nov 15, 2010146-day reviewClass U

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

Depuy Spine, Inc. · MRW System, Facet Screw Spinal Device

Cleared on Nov 15, 2010 as substantially equivalent to K012773 (Depuyacromed, 2001) and 6 other predicates after a 146-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it.

Decided
Nov 15, 2010
Review
146 days
Class
Class U
Product code
MRW
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K020411 (2002). 19 ancestors in all, the oldest K953076 (1997). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 2 other ancestors2006: 1 other ancestor2004: 2 other ancestors2001: 2 other ancestors2003: 3 other ancestors2000: 1 other ancestor2005: 1 other ancestor1997: 1 other ancestor2019: 1 descendant clearedK020411 · Nuvasive Triad Facet Screw System · Nuvasive, Inc. · 2002K043351 · 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N · Triage Medical, Inc. · 2005 · recalledK062391 · Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00 · Triage Medical, Inc. · 2006 · recalledK082795 · Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant · Interventional Spine, Inc. · 2008K090767 · Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer · Interventional Spine, Inc. · 20091995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 7 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant K090767 · Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer · Interventional Spine, Inc. · 2009K082795 · Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant · Interventional Spine, Inc. · 2008K062391 · Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00 · Triage Medical, Inc. · 2006 · recalledK043351 · 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N · Triage Medical, Inc. · 2005 · recalledK020411 · Nuvasive Triad Facet Screw System · Nuvasive, Inc. · 2002−50
  1. Root · 5 generations backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
  2. 4 generations backK043351 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S…Triage Medical, Inc. · 2005 · Recalled
  3. 3 generations backK062391 Disposable Posterior Lumbar Stabilization Procedure Kit, Models…Triage Medical, Inc. · 2006 · Recalled
  4. 2 generations backK082795 Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc. · 2008
  5. 1 generation backK090767 Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc. · 2009
  6. This deviceK101762 Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010
  7. Descendant · cites it directly · 0 of its ownK192281 AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System…Medos International SARL · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K020411Nuvasive Triad Facet Screw SystemNuvasive, Inc.2002—
−4K0433514.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NTriage Medical, Inc.20051
−3K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and…Triage Medical, Inc.20061
−2K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc.2008—
−1K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc.2009—
0 (this device)K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.2010—
+1K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior…Medos International SARL2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200120
200330
200420
200510
200610
200820
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K101762, 2002–2019Source: 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 MRW? 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 MRW device

  1. #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K012773Discovery Facet Screw Fixation System
Summary page 1
…Panel Number: 87 Product Code(s): MRW Proprietary Name: VIPER® F2 Facet Fixation System Predicate Devices: DISCOVERY Facet Screw Fixation System (K012773) PERPOS FCD-2 System (K090767) Capture Facet Screw System (K092464)…
Depuyacromed2001—
*K090767Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer
Summary page 1
…oprietary Name: VIPER® F2 Facet Fixation System Predicate Devices: DISCOVERY Facet Screw Fixation System (K012773) PERPOS FCD-2 System (K090767) Capture Facet Screw System (K092464) Facet Fixation System (K06 1041)…
Interventional Spine, Inc.2009—
*K092464Spineology Facet Screw
Summary page 1
…Devices: DISCOVERY Facet Screw Fixation System (K012773) PERPOS FCD-2 System (K090767) Capture Facet Screw System (K092464) Facet Fixation System (K06 1041) Triad Facet Screw System (K02041 1)…
Spineology, Inc.2009—
*K061041US Spine Facet Fixation System
Summary page 1
…) PERPOS FCD-2 System (K090767) Capture Facet Screw System (K092464) Facet Fixation System (K06 1041) Triad Facet Screw System (K02041 1) Chameleon Fixation System (K07 1420)…
Us Spine2006—
*K020411Nuvasive Triad Facet Screw System
Summary page 1
…Capture Facet Screw System (K092464) Facet Fixation System (K06 1041) Triad Facet Screw System (K02041 1) Chameleon Fixation System (K07 1420) VIPER System (K041801) Device Des…
Nuvasive, Inc.2002—
*K071420Chameleon Fixation System
Summary page 1
…Facet Fixation System (K06 1041) Triad Facet Screw System (K02041 1) Chameleon Fixation System (K07 1420) VIPER System (K041801) Device Description: The screws and washers that are the subject component…
Spinefrontier, Inc.20081
*K041801Expedium Mis Spine System
Summary page 1
…041) Triad Facet Screw System (K02041 1) Chameleon Fixation System (K07 1420) VIPER System (K041801) Device Description: The screws and washers that are the subject components of this submission are…
Depuy Spine, Inc.2004—

Also cleared against K012773: 13 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190

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 8 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 3 of the 19 ancestors have a recall of any class.
  • Of its descendants, K192281 (Medos International SARL, 2019) has gone furthest, with 0 descendants of its own.
  • 13 other devices also cite its predicate K012773.

How does its category compare?

All MRW devices

MRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MRW

7in 2025

2008: 32009: 62010: 62011: 32012: 42013: 72015: 22016: 22017: 12018: 22019: 32022: 32023: 32024: 72025: 72026 (partial year): 5
2007high 7 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRW

97in 2025

2008: 88 days median2009: 89 days median2010: 108 days median2011: 122 days median2012: 119 days median2013: 110 days median2019: 90 days median2022: 252 days median2023: 190 days median2024: 50 days median2025: 97 days median2026 (partial year): 169 days median
2007high 252 (2022) · low 50 (2024)2026

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

Recalls per year · MRW

3in 2011

2011: 3
2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MRW

3in 2025

2007: 12009: 22010: 72011: 622012: 62013: 42014: 12015: 22016: 12017: 42018: 42021: 12023: 12024: 22025: 3
2007high 62 (2011) · low 0 (2008)2025

MAUDE reports naming product code MRW, 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
20070—01
200838800
200968902
2010610807
20113122362
2012411906
2013711004
20140—01
20152—02
20162—01
20171—04
20182—04
201939000
20200—00
20210—01
2022325200
2023319001
202475002
202579703
202651690—

What is it indicated for?

The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only: Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. This system is indicated for the posterior surgical treatment of any or all of the following at the LI to SI (inclusive) spinal levels: 1) Trauma, including spinal fractures…

Read the full statement (141 words)

The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:

Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.

This system is indicated for the posterior surgical treatment of any or all of the following at the LI to SI (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

Indications for use as stated in the FDA summary.

Also cleared against K012773

13 other devices cite the same predicate.

  • K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset…Lesspine Innovations · 2023
  • K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI…Medos International SARL · 2019
  • K173198Facet Screw Fixation SystemU&I Corporation · 2018
  • K131417Facet FixxNexxt Spine, LLC · 2013
  • K123497Facet Screw SystemFacet-Link, Inc. · 2013
  • K121850Typhoon (TM) Facet Screw Fixation SystemChoicespine, LP · 2012

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 MRW

The MRW category page

  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K261209Ion-LSurGenTec, LLC · 2026
  • K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026
  • K253432DiversiVy™ Facet Screw SystemVy Spine, LLC · 2026
  • K251714Ion-CSurGenTec, LLC · 2026

https://510kreport.com/device/K101762 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101762: Viper F2 Facet Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101762

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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