510(k) Report

510(k) · Cleared

Cleared

Valeo Cervical Plate System

K071990510(k) TraditionalCleared Oct 29, 2007101-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

Amedica Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Oct 29, 2007 as substantially equivalent to K982443 (Depuy Motech Acromed, 1998) and 8 other predicates after a 101-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.

Decided
Oct 29, 2007
Review
101 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
9

Its longest line of descent runs back 4 generations to K922087 (1992). 24 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1999: 5 other ancestors1998: 4 other ancestors1997: 3 other ancestors1995: 1 other ancestor1993: 2 other ancestors2008: 1 descendant clearedK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK000486 · Abc Cervical Plating System · Aesculap, Inc. · 2000K040017 · Abc Caudal and Cranial Extension Plate (E-Plate) · Aesculap, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 6 other ancestors3 generations back: 6 other ancestors 1 generation forward: 1 descendant K040017 · Abc Caudal and Cranial Extension Plate (E-Plate) · Aesculap, Inc. · 2004K000486 · Abc Cervical Plating System · Aesculap, Inc. · 2000K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 19920
  1. Root · 4 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 3 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 2 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. 1 generation backK040017 Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc. · 2004
  5. This deviceK071990 Valeo Cervical Plate SystemAmedica Corp. · 2007
  6. Descendant · cites it directly · 0 of its ownK082037 Seeplate Cervical Plate SystemAmedica Corp. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K082037Seeplate Cervical Plate SystemAmedica Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−3K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−2K000486Abc Cervical Plating SystemAesculap, Inc.2000—
−1K040017Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc.2004—
0 (this device)K071990Valeo Cervical Plate SystemAmedica Corp.2007—
+1K082037Seeplate Cervical Plate SystemAmedica Corp.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199510
199730
199840
199950
200010
200120
200210
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K071990, 1992–2008Source: 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
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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
*K982443Doc Ventral Cervical Stabilization System
Summary page 2
…lly equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The cited references include: * DePuy DOC (K982443) * Medtronic Atlantis (K021461) * Medtronic Orion (K973854) * Synthes Anterior CSLP System (K000536) * Theken…
Depuy Motech Acromed1998—
*K021461Atlantis Vision Anterior Cervical Plate System
Summary page 2
…devices and has the same indications for use, design, function, and materials used. The cited references include: * DePuy DOC (K982443) * Medtronic Atlantis (K021461) * Medtronic Orion (K973854) * Synthes Anterior CSLP System (K000536) * Theken Tether ACFS (K010466) * EBI/Bi…
Medtronic Sofamor Danek20023
*K973854Orion Anterior Cervical Plate System
Summary page 2
…ions for use, design, function, and materials used. The cited references include: * DePuy DOC (K982443) * Medtronic Atlantis (K021461) * Medtronic Orion (K973854) * Synthes Anterior CSLP System (K000536) * Theken Tether ACFS (K010466) * EBI/Biomet Vuelock (K010003) * NuV…
Sofamor Danek USA,Inc.1998—
*K000536Synthes Anterior CSLP System
Summary page 2
…used. The cited references include: * DePuy DOC (K982443) * Medtronic Atlantis (K021461) * Medtronic Orion (K973854) * Synthes Anterior CSLP System (K000536) * Theken Tether ACFS (K010466) * EBI/Biomet Vuelock (K010003) * NuVasive SmartPlate Gradient Plus (K053581) *…
Synthes Spine20001
*K010466Tether Acfs
Summary page 2
…* DePuy DOC (K982443) * Medtronic Atlantis (K021461) * Medtronic Orion (K973854) * Synthes Anterior CSLP System (K000536) * Theken Tether ACFS (K010466) * EBI/Biomet Vuelock (K010003) * NuVasive SmartPlate Gradient Plus (K053581) * EBI SpineLink (K992920) * Aes…
Theken Surgical,Llc2001—
*K010003Ebi Vuelock Anterior Cervical Plate System
Summary page 2
…edtronic Atlantis (K021461) * Medtronic Orion (K973854) * Synthes Anterior CSLP System (K000536) * Theken Tether ACFS (K010466) * EBI/Biomet Vuelock (K010003) * NuVasive SmartPlate Gradient Plus (K053581) * EBI SpineLink (K992920) * Aesculap ABC - Extension Plate (K040017…
Ebi, L.P.2001—
*K053581Nuvasive Smartplate Gradient Plus System
Summary page 2
…(K973854) * Synthes Anterior CSLP System (K000536) * Theken Tether ACFS (K010466) * EBI/Biomet Vuelock (K010003) * NuVasive SmartPlate Gradient Plus (K053581) * EBI SpineLink (K992920) * Aesculap ABC - Extension Plate (K040017) Performance Standards: Testing performed on thi…
Nuvasive, Inc.2006—
*K992920Ebi Spinelink System
Summary page 2
…or CSLP System (K000536) * Theken Tether ACFS (K010466) * EBI/Biomet Vuelock (K010003) * NuVasive SmartPlate Gradient Plus (K053581) * EBI SpineLink (K992920) * Aesculap ABC - Extension Plate (K040017) Performance Standards: Testing performed on this device indicates that the Val…
Ebi, L.P.1999—
*K040017Abc Caudal and Cranial Extension Plate (E-Plate)
Summary page 2
…FS (K010466) * EBI/Biomet Vuelock (K010003) * NuVasive SmartPlate Gradient Plus (K053581) * EBI SpineLink (K992920) * Aesculap ABC - Extension Plate (K040017) Performance Standards: Testing performed on this device indicates that the ValeoTM Cervical Plate System is substantially equi…
Aesculap, Inc.2004—

Also cleared against K982443: 6 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
K082037Seeplate Cervical Plate SystemAmedica Corp.20080

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 15 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
  • 3 of the 24 ancestors have a recall of any class.
  • Of its descendants, K082037 (Amedica Corp., 2008) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K982443.

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. 2007, 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 ValeoTM Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The ValeoTM Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis…

Read the full statement (117 words)

The ValeoTM Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The ValeoTM Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Indications for use as stated in the FDA summary.

Also cleared against K982443

6 other devices cite the same predicate.

  • K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
  • K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
  • K112809Blue Mountain Cervical PlateQualgenix, LLC · 2012
  • K073500Active Anterior Cervical Plate SystemSanacor · 2008
  • K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
  • K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005

More from Amedica Corp.

16 FDA decisions under this applicant name. See the company

  • K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp. · 2018
  • K161405Valeo II Interbody Fusion Device SystemAmedica Corp. · 2016
  • K143518Valeo Spacer System and Valeo II Interbody Fusion Device SystemAmedica Corp. · 2015
  • K142264Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp. · 2014
  • K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp. · 2014

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/K071990 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071990: Valeo 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/K071990

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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