510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Virage Oct Spinal Fixation System

K133556510(k) TraditionalCleared Jun 2, 2014195-day reviewClass II21 CFR 888.3050Recalls 2

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

Zimmer Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jun 2, 2014 as substantially equivalent to K070282 (Endius, Inc., 2007) and 6 other predicates after a 195-day review. Its family tree reaches back 13 generations to 2001. 27 later devices descend from it. It has been recalled 2 times.

Decided
Jun 2, 2014
Review
195 days
Class
Class II
Product code
KWP
Recalls
2
Predicates
7

Its longest line of descent runs back 13 generations to K003155 (2001). 85 ancestors in all, the oldest K841189 (1984). 27 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 4 other ancestors2007: 3 other ancestors2001: 6 other ancestors1999: 3 other ancestors2008: 2 other ancestors2006: 5 other ancestors2004: 17 other ancestors2005: 9 other ancestors2002: 7 other ancestors2000: 6 other ancestors1998: 2 other ancestors2003: 5 other ancestors1997: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestor2015: 2 descendants cleared2018: 2 descendants cleared2017: 3 descendants cleared2016: 4 descendants cleared2020: 3 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2019: 1 descendant cleared2024: 3 descendants cleared2023: 2 descendants cleared2026: 4 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004×3: 3 generations cleared close together, K060719 (2006), K061938 (2006), K062427 (2006) K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K123656 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 6 other ancestors3 generations back: 13 other ancestors4 generations back: 10 other ancestors5 generations back: 6 other ancestors6 generations back: 12 other ancestors7 generations back: 18 other ancestors8 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 9 descendants3 generations forward: 8 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants K123656 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2013K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K062427 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K061938 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−10−50+5
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 9 generations between
  3. 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  4. 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  5. 1 generation backK123656 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2013
  6. This deviceK133556 Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014
  7. Descendant · cites it directly · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
  8. Descendant · cites it directly · 13 of its ownK150918 PASS OCT Spinal SystemMedicrea International SA · 2015
  9. Descendant · cites it directly · 5 of its ownK182182 YUKON OCT Spinal SystemK2m · 2018
  10. Descendant · 2 generations on · 5 of its ownK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
  11. Descendant · 2 generations on · 5 of its ownK173522 Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017
Show all 13 generations
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 12 generations backK012254 VBROsteotech, Inc. · 2001
  3. 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 9 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 8 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 7 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 6 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 5 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 4 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 1 generation backK123656 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2013
  14. This deviceK133556 Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2015: 22016: 42017: 32018: 22019: 12020: 32021: 12022: 22023: 22024: 32026: 4
2015high 4 (2016) · low 0 (2025)2026

Most influential descendants

Showing 5 of 27 · See all
  • K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · cites it directly13descendants
  • K150918PASS OCT Spinal SystemMedicrea International SA · 2015 · cites it directly13descendants
  • K182182YUKON OCT Spinal SystemK2m · 2018 · cites it directly5descendants
  • K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc. · 2018 · 2 generations on5descendants
  • K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−12K012254VBROsteotech, Inc.2001—
−11K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−10K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−9K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−8K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−6K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−5K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−4K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−3K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−1K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2013—
0 (this device)K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014—
+1K171444YUKON OCT Spinal SystemK2m, Inc.20173
+1K150918PASS OCT Spinal SystemMedicrea International SA2015—
+1K182182YUKON OCT Spinal SystemK2m2018—
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT…K2m, Inc.2018—
+2K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199710
199820
199930
200060
200160
200270
200350
2004170
200590
200650
200730
200820
200940

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201640
201730
201820
201910
202030
202110
202220
202320
202430
202640
FIG. 1 — Lineage of K133556, 2001–2026Source: 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation System
Summary page 3
…Predicate Device Name FDA 510k Number Endius Minit Posterior Cervical and Upper Thoracic Fixation K070282 System ______________ __ NuVasive®)OCT System…
Endius, Inc.2007—
*K071435Nuvasive Oct System
Summary page 3
…System ______________ __ NuVasive®)OCT System K071435 Synthes Synapse, Cervifix, Cervifix Starlock K091689, K991089, K994187 Vertex Reconstructive System…
Nuvasive, Inc.2007—
*K091689Synapse System 4.0MM, OC Fusion System 4.0MM
Summary page 3
…__ __ NuVasive®)OCT System K071435 Synthes Synapse, Cervifix, Cervifix Starlock K091689, K991089, K994187 Vertex Reconstructive System K003780, K123656 Substantial Equivalen…
Synthes (Usa)2009—
*K991089Synthes Cervifix System
Summary page 3
…__ NuVasive®)OCT System K071435 Synthes Synapse, Cervifix, Cervifix Starlock K091689, K991089, K994187 Vertex Reconstructive System K003780, K123656 Substantial Equivalence: Zi…
Synthes Spine1999—
*K994187Synthes Cervifix System
Summary page 3
…NuVasive®)OCT System K071435 Synthes Synapse, Cervifix, Cervifix Starlock K091689, K991089, K994187 Vertex Reconstructive System K003780, K123656 Substantial Equivalence: Zimmer Spin…
Synthes (Usa)1999—
*K003780Vertex Reconstruction System
Summary page 3
…71435 Synthes Synapse, Cervifix, Cervifix Starlock K091689, K991089, K994187 Vertex Reconstructive System K003780, K123656 Substantial Equivalence: Zimmer Spine considers the subject Virago OCT Spinal Fixation System product performanc…
Medtronic Sofamor Danek, Inc.2001—
*K123656Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 3
…Synthes Synapse, Cervifix, Cervifix Starlock K091689, K991089, K994187 Vertex Reconstructive System K003780, K123656 Substantial Equivalence: Zimmer Spine considers the subject Virago OCT Spinal Fixation System product performance to be s…
Medtronic Sofamor Danek USA, Inc.2013—

Also cleared against K070282: 3 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K171444YUKON OCT Spinal SystemK2m, Inc.201713
K150918PASS OCT Spinal SystemMedicrea International SA201513
K182182YUKON OCT Spinal SystemK2m20185
K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20152

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 3, 2016Class IIZ-1019-2016Under Investigation by firmZimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.
Nov 17, 2015Class IIZ-0625-2016Process controlZimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 9 months on median.
  • 5 of the 85 ancestors have a recall of any class.
  • Of its descendants, K171444 (K2m, Inc., 2017) has gone furthest, with 13 descendants of its own.
  • 3 other devices also cite its predicate K070282.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following: Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Occipitocervical…

Read the full statement (232 words)

When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following:

Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Plate/Rod/Occipital Screws/Hooks

Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine.

Hooks and Rods

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Thoracic Screws

The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.

Rod Connectors

The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods.

The titanium SONGER Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Indications for use as stated in the FDA summary.

Also cleared against K070282

3 other devices cite the same predicate.

  • K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical…Zimmer Spine, Inc. · 2015
  • K080258Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008
  • K073267Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008

More from Zimmer Spine, Inc.

52 FDA decisions under this applicant name. See the company

  • K153631Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2016
  • K150896Vitality Spinal Fixation SystemZimmer Spine, Inc. · 20153 recalls
  • K151031Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2015
  • K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical…Zimmer Spine, Inc. · 2015
  • K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix…Zimmer Spine, Inc. · 2015

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K133556 · printed Nov 5, 2026

Cite this page

510(k) Report. “K133556: Virage Oct Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133556

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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