510(k) Report

510(k) · Cleared

Cleared

Oria Zenith

K030500510(k) SpecialCleared Mar 20, 200329-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

Ortho Tec, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Mar 20, 2003 after a 29-day review. The FDA summary names no predicate by number. 11 later devices descend from it.

Decided
Mar 20, 2003
Review
29 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

11 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2019: 2 descendants cleared2024: 2 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared2025: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK030500 Oria ZenithOrtho Tec, LLC · 2003
  2. Descendant · cites it directly · 5 of its ownK103137 Venus Anterior Cervical PlateVerticor, Ltd. · 2011
  3. Descendant · cites it directly · 4 of its ownK190227 Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
  4. Descendant · 2 generations on · 4 of its ownK111132 Genesys Spine Anterior Cervical Plate SystemGenesys Spine · 2011 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
  6. Descendant · 3 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 22013: 12014: 12017: 12019: 22024: 22025: 12026: 1
2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 11 · See all
  • K103137Venus Anterior Cervical PlateVerticor, Ltd. · 2011 · cites it directly5descendants
  • K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019 · cites it directly4descendants
  • K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine · 2011 · 2 generations on4descendants
  • K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 2 generations on2descendants
  • K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030500Oria ZenithOrtho Tec, LLC2003—
+1K103137Venus Anterior Cervical PlateVerticor, Ltd.2011—
+1K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP2019—
+2K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine20111
+2K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.2024—
+3K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201310
201410
201710
201920
202420
202510
202610
FIG. 1 — Lineage of K030500, 2003–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K103137Venus Anterior Cervical PlateVerticor, Ltd.20115
K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194

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?

  • Of its descendants, K103137 (Verticor, Ltd., 2011) has gone furthest, with 5 descendants of its own.

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.

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 ORIA ZENITH is intended for anterior screw fixation of the cervical spine and is designed to

provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this

device include failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma,

spondylolisthesis or degenerative disc disease defined as neck pain of discogenic origin with the

degeneration of the disc confirmed by history and radiographic studies.

WARNING: The ORIA ZENITH is not intended for screw attachment or fixation to the posterior

elements (pedicles) of the cervical, thoracic or lumbar spine.

Indications for use as stated in the FDA summary.

More from Ortho Tec, LLC

22 FDA decisions under this applicant name. See the company

  • K040514Eovia Calcium Phosphate CeramicOrtho Tec, LLC · 2004
  • K040346Modification to Oria Top Clip SystemOrtho Tec, LLC · 2004
  • K030958Oria Spinal System, Domino and Tube ConnectorsOrtho Tec, LLC · 2003
  • K031471Oria Spinal Clip System, Lateral Intermediate Connector, Model AL01Ortho Tec, LLC · 2003
  • K023884Modification Oria Spinal SystemOrtho Tec, LLC · 2003

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/K030500 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030500: Oria Zenith.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030500

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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