510(k) Report

510(k) · Cleared

Cleared

Venus Anterior Cervical Plate

K103137510(k) TraditionalCleared Feb 10, 2011108-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

Verticor, Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Feb 10, 2011 as substantially equivalent to K052292 (X-Spine Systems, Inc., 2005) and 7 other predicates after a 108-day review. Its family tree reaches back 5 generations to 1998. 5 later devices descend from it.

Decided
Feb 10, 2011
Review
108 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
8

Its longest line of descent runs back 5 generations to K973854 (1998). 21 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 3 other ancestors2003: 2 other ancestors2001: 2 other ancestors2000: 1 other ancestor1995: 2 other ancestors2007: 1 other ancestor2002: 1 other ancestor1997: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2011: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant clearedK973854 · Orion Anterior Cervical Plate System · Sofamor Danek USA,Inc. · 1998×2: 2 generations cleared close together, K042235 (2004), K042922 (2004) K061274 · Venture Anterior Cervical Plate System · Medtronic Sofamor Danek · 2006K102820 · Appliance, Fixation, Spinal Intervertebral Body · Alphatec Spine, Inc. · 2010 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors4 generations back: 2 other ancestors5 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants K102820 · Appliance, Fixation, Spinal Intervertebral Body · Alphatec Spine, Inc. · 2010 · recalledK061274 · Venture Anterior Cervical Plate System · Medtronic Sofamor Danek · 2006K042922 · Venture Anterior Cervical Plating System · Medtronic Sofamor Danek, Inc. · 2004K042235 · Orion Anterior Cervical Plating System · Medtronic Sofamor Danek · 2004K973854 · Orion Anterior Cervical Plate System · Sofamor Danek USA,Inc. · 1998−50
  1. Root · 5 generations backK973854 Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1998
  2. 4 generations backK042235 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
  3. 3 generations backK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
  4. 2 generations backK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
  5. 1 generation backK102820 Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · Recalled
  6. This deviceK103137 Venus Anterior Cervical PlateVerticor, Ltd. · 2011
  7. Descendant · cites it directly · 4 of its ownK111132 Genesys Spine Anterior Cervical Plate SystemGenesys Spine · 2011 · Recalled
  8. Descendant · 2 generations on · 1 of its ownK133245 Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014 · Recalled
  9. Descendant · 2 generations on · 1 of its ownK131512 Katia SystemShanghai Sanyou Medical Co, Ltd. · 2013
  10. Descendant · 3 generations on · 0 of its ownK192076 Binary® Anterior Cervical Plate SystemGenesys Spine · 2019
  11. Descendant · 3 generations on · 0 of its ownK163366 Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd. · 2017

Most influential descendants

Showing 5 of 5 · See all
  • K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine · 2011 · cites it directly4descendants
  • K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014 · 2 generations on1descendant
  • K131512Katia SystemShanghai Sanyou Medical Co, Ltd. · 2013 · 2 generations on1descendant
  • K192076Binary® Anterior Cervical Plate SystemGenesys Spine · 2019 · 3 generations on0descendants
  • K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K973854Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc.1998—
−4K042235Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004—
−3K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc.2004—
−2K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek2006—
−1K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.20102
0 (this device)K103137Venus Anterior Cervical PlateVerticor, Ltd.2011—
+1K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine20111
+2K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine20141
+2K131512Katia SystemShanghai Sanyou Medical Co, Ltd.2013—
+3K192076Binary® Anterior Cervical Plate SystemGenesys Spine2019—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199520
199710
200010
200120
200210
200320
200430
200510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201310
201410
201710
201910
FIG. 1 — Lineage of K103137, 1998–2019Source: 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 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? (9)

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
*K052292Spider Cervical Plating (SCP) System
Summary page 1
…KWQ 3. Predicate or legally marketed devices which are substantially equivalent: Spider Cervical Plating System [X-Spine Systems, K0522921 ORIA ZENITH [Eurosurgical, SA, K030500/1<001535] *Synthes Anterior CLSP System [Synthes Spine, K000536/K9457001…
X-Spine Systems, Inc.2005—
*K030500Oria Zenith
Summary page 1
…te or legally marketed devices which are substantially equivalent: Spider Cervical Plating System [X-Spine Systems, K0522921 ORIA ZENITH [Eurosurgical, SA, K030500/1<001535] *Synthes Anterior CLSP System [Synthes Spine, K000536/K9457001 Trestle Anterior Cervical Plating System […
Ortho Tec, LLC2003—
*K001535Zenith Plate System, Anterior Spinal Instrumentation
Summary page 1
…Verticor, LTD X-Spine Systems Eurosurgical, SA Synthes Spine 510(k) Number N/A K052292 K0305001K001535 K000536/K945700 Plate material Titanium alloy per Titanium alloy per Titanium alloy per Titani…
Ortho Tec, LLC2001—
*K000536Synthes Anterior CSLP System
Summary page 1
…Spider Cervical Plating System [X-Spine Systems, K0522921 ORIA ZENITH [Eurosurgical, SA, K030500/1<001535] *Synthes Anterior CLSP System [Synthes Spine, K000536/K9457001 Trestle Anterior Cervical Plating System [Alphatec, K1028201 SmartLOX Anterior Cervical Plate [Captiva,]…
Synthes Spine20001
*K945700Synthes (Usa) Anterior Cervical Vertebrae Plate System
Summary page 1
…r Cervical Plating System [X-Spine Systems, K0522921 ORIA ZENITH [Eurosurgical, SA, K030500/1<001535] *Synthes Anterior CLSP System [Synthes Spine, K000536/K9457001 Trestle Anterior Cervical Plating System [Alphatec, K1028201 SmartLOX Anterior Cervical Plate [Captiva,] 4. Des…
Synthes (Usa)1995—
*K102820Appliance, Fixation, Spinal Intervertebral Body
Cleared while this submission was under review
Summary page 1
…ITH [Eurosurgical, SA, K030500/1<001535] *Synthes Anterior CLSP System [Synthes Spine, K000536/K9457001 Trestle Anterior Cervical Plating System [Alphatec, K1028201 SmartLOX Anterior Cervical Plate [Captiva,] 4. Description of the device: The VENUS Anterior Cervical Plate is…
Alphatec Spine, Inc.20102
*K031276Synthes Anterior Cervical Locking Plate (Aclp) System
Summary page 2
…r, LTD Aiphatec Captiva Synthes 510(k) Number N/A K102820 K031276/K033844 Plate material Titanium alloy per Titanium alloy per Titanium alloy per titanium alloy per…
Synthes (Usa)2003—
*K033844Synthes Anterior Cervical Compression System
Summary page 2
…Aiphatec Captiva Synthes 510(k) Number N/A K102820 K031276/K033844 Plate material Titanium alloy per Titanium alloy per Titanium alloy per titanium alloy per…
Synthes (Usa)2004—
*—SmartLOX Anterior Cervical Plate
Named without a submission number
—

Also cleared against K052292: 14 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine20114

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 13 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
  • 3 of the 21 ancestors have a recall of any class.
  • Of its descendants, K111132 (Genesys Spine, 2011) has gone furthest, with 4 descendants of its own.
  • 14 other devices also cite its predicate K052292.

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 VENUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: * degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of…

Read the full statement (139 words)

The VENUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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),

* spondylotisthesis,

* trauma (i.e. fractures or dislocations),

* tumors,

* deformity (defined as kyphosis, lordlosis, or scoliosis),

* pseudlarthrosis,

* failed previous fusion,

* spinal stenosis.

WARNING: The VENUS Anterior Cervical Plate System 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.

Also cleared against K052292

14 other devices cite the same predicate.

  • K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  • K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart · 2018
  • K170224Spider Cervical Plating SystemX-Spine Systems, Inc. · 2017
  • K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 20167 recalls
  • K150834Atrax Anterior Cervical Plating SystemX-Spine Systems, Inc. · 2015

More from Verticor, Ltd.

3 FDA decisions under this applicant name. See the company

  • K110047Verticor K-Wire SystemVerticor, Ltd. · 2011
  • K091426Cervicore Corpectomy CageVerticor, Ltd. · 2009

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/K103137 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103137: Venus Anterior Cervical Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103137

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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