510(k) Report

510(k) · Cleared

Cleared

Kinetic Anterior Cervical Plate

K062643510(k) SpecialCleared Nov 16, 200671-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

Life Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 16, 2006 as substantially equivalent to K040844 (Life Spine, LLC, 2004) after a 71-day review. Its family tree reaches back 2 generations to 2000. 53 later devices descend from it.

Decided
Nov 16, 2006
Review
71 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K002592 (2000). 3 ancestors in all. 53 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2008: 1 descendant cleared2010: 1 descendant cleared2012: 2 descendants cleared2013: 1 descendant cleared2016: 1 descendant cleared2022: 4 descendants cleared2017: 2 descendants cleared2014: 2 descendants cleared2019: 3 descendants cleared2015: 1 descendant cleared2020: 4 descendants cleared2018: 1 descendant cleared2024: 6 descendants cleared2023: 4 descendants cleared2021: 3 descendants cleared2026: 8 descendants cleared2025: 9 descendants clearedK002592 · Interpore Cross Anterior Cervical Plate System · Interpore Cross Intl. · 2000K040844 · Life Spine Neo Anterior Cervical Plate System · Life Spine, LLC · 2004200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 7 descendants4 generations forward: 12 descendants5 generations forward: 8 descendants6 generations forward: 12 descendants7 generations forward: 7 descendants8 generations forward: 5 descendants K040844 · Life Spine Neo Anterior Cervical Plate System · Life Spine, LLC · 2004K002592 · Interpore Cross Anterior Cervical Plate System · Interpore Cross Intl. · 20000+5
  1. Root · 2 generations backK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
  2. 1 generation backK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
  3. This deviceK062643 Kinetic Anterior Cervical PlateLife Spine · 2006
  4. Descendant · cites it directly · 52 of its ownK073479 Kinetic-SL Anterior Cervical Plate SystemLife Spine · 2008
  5. Descendant · 2 generations on · 51 of its ownK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
  6. Descendant · 3 generations on · 19 of its ownK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
  7. Descendant · 3 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
  8. Descendant · 4 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12012: 22013: 12014: 22015: 12016: 12017: 22018: 12019: 32020: 42021: 32022: 42023: 42024: 62025: 92026: 8
2008high 9 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 53 · See all
  • K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine · 2008 · cites it directly52descendants
  • K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010 · 2 generations on51descendants
  • K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014 · 3 generations on19descendants
  • K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 3 generations on18descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 4 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002592Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl.2000—
−1K040844Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC2004—
0 (this device)K062643Kinetic Anterior Cervical PlateLife Spine2006—
+1K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine2008—
+2K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.2010—
+3K142060Transom Anterior Cervical PlateNeurostructures, Inc.2014—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC2017—
+4K190016Lateral Plate SystemCorelink, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201220
201310
201420
201510
201610
201720
201810
201930
202040
202130
202240
202340
202460
202590
202680
FIG. 1 — Lineage of K062643, 2000–2026Source: 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
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What was it cleared against? (1)

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
*K040844Life Spine Neo Anterior Cervical Plate System
Summary page 1
…Class 11 Device Product Code: KWQ Predicate Device: NEOTM Anterior Cervical Plate System K040844 and other predicate devices Device Description: The K[NETICTM Anterior Cer…
Life Spine, LLC2004—

Also cleared against K040844: 3 other devices →

What descends from it? (53)

See all 53

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

NumberDeviceApplicantDecidedDescendants
K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine200852

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 6 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K073479 (Life Spine, 2008) has gone furthest, with 52 descendants of its own.
  • 3 other devices also cite its predicate K040844.

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 KINETICTM Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to TI during the development of a cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal cord stenosis; deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); tumors; pseudarthrosis; and / or failed previous fusions.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K062643: Kinetic 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/K062643

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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