510(k) Report

510(k) · Cleared

Cleared

Invizia Anterior Cervical Plate System

K111796510(k) TraditionalCleared Oct 27, 2011122-day reviewClass II21 CFR 888.3060

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

Zimmer Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Oct 27, 2011 as substantially equivalent to K022344 (Centerpulse Spine-Tech, Inc., 2002) and 2 other predicates after a 122-day review. Its family tree reaches back 3 generations to 1993. 18 later devices descend from it.

Decided
Oct 27, 2011
Review
122 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K926453 (1993). 8 ancestors in all. 18 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestor2015: 1 descendant cleared2020: 2 descendants cleared2023: 7 descendants cleared2024: 2 descendants cleared2021: 2 descendants cleared2026: 2 descendants cleared2022: 2 descendants clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 1993K971883 · Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 1997 · recalledK022344 · Trinica Select Anterior Cervical Plate System · Centerpulse Spine-Tech, Inc. · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants K022344 · Trinica Select Anterior Cervical Plate System · Centerpulse Spine-Tech, Inc. · 2002 · recalledK971883 · Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 1997 · recalledK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930+5
  1. Root · 3 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. 2 generations backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
  3. 1 generation backK022344 Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc. · 2002 · Recalled
  4. This deviceK111796 Invizia Anterior Cervical Plate SystemZimmer Spine, Inc. · 2011
  5. Descendant · cites it directly · 16 of its ownK143626 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic…Zimmer Spine, Inc. · 2015
  6. Descendant · 2 generations on · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
  7. Descendant · 3 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
  8. Descendant · 4 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
  9. Descendant · 2 generations on · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2015: 12020: 22021: 22022: 22023: 72024: 22026: 2
2015high 7 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 18 · See all
  • K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc. · 2015 · cites it directly16descendants
  • K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · 2 generations on13descendants
  • K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 3 generations on10descendants
  • K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 4 generations on6descendants
  • K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
−2K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa)19971
−1K022344Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc.20021
0 (this device)K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc.2011—
+1K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical…Zimmer Spine, Inc.2015—
+2K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.2020—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System…Aegis Spine2021—
+4K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon…Aegis Spine, Inc.2022—
+2K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810
200010
200110
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202020
202120
202220
202370
202420
202620
FIG. 1 — Lineage of K111796, 1993–2026Source: 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 KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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? (3)

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
*K022344Trinica Select Anterior Cervical Plate System
Summary page 1
…fication: Class 11 Predicate Devices: Zimmer Spine Trinica®0 Select Anterior Cervical Plate System (K022344) Synthes 0Spine Anterior CSLP System (K030866 and K971…
Centerpulse Spine-Tech, Inc.20021
*K030866Synthes Anterior CSLP System
Summary page 1
…Trinica®0 Select Anterior Cervical Plate System (K022344) Synthes 0Spine Anterior CSLP System (K030866 and K971 883) Description of Device: The inViZiaTM Anterior Cervical Plate System is a tem…
Synthes (Usa)2003—
*K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System
Summary page 1
…System (K022344) Synthes 0Spine Anterior CSLP System (K030866 and K971 883) Description of Device: The inViZiaTM Anterior Cervical Plate System is a temporary implant system used to facilitate the biolo…
Synthes (Usa)19971

Also cleared against K022344: 5 other devices →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc.201516
K200927Transept Cervical Plate SystemNeurostructures, Inc.20200

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 18 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K143626 (Zimmer Spine, Inc., 2015) has gone furthest, with 16 descendants of its own.
  • 5 other devices also cite its predicate K022344.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The inViZia TM Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1. The inViZia TM Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and…

Read the full statement (110 words)

The inViZia TM Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1.

The inViZia TM Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K022344

5 other devices cite the same predicate.

  • K210182PANAMA™ Anterior Cervical Plate (ACP) SystemFlospine · 2021
  • K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate SystemZimmer Spine, Inc. · 2013
  • K122497Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate System, One Level, 16MMMedical Design, LLC · 2012
  • K040003Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
  • K031214Cyclone Anterior Cervical Plate SystemEncore Medical L.P. · 200332 recalls

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 KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K111796 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111796: Invizia Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111796

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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