510(k) Report

510(k) · Cleared

Cleared

Life Spine Neo Anterior Cervical Plate System

K040844510(k) TraditionalCleared Jul 23, 2004113-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, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jul 23, 2004 as substantially equivalent to K002592 (Interpore Cross Intl., 2000) and 1 other predicate after a 113-day review. Its family tree reaches back 1 generation to 2000. 77 later devices descend from it.

Decided
Jul 23, 2004
Review
113 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K002592 (2000). 2 ancestors in all. 77 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2007: 1 descendant cleared2011: 2 descendants cleared2006: 2 descendants cleared2008: 1 descendant cleared2010: 2 descendants cleared2015: 2 descendants cleared2013: 2 descendants cleared2012: 3 descendants cleared2023: 5 descendants cleared2024: 9 descendants cleared2017: 2 descendants cleared2016: 3 descendants cleared2022: 6 descendants cleared2014: 3 descendants cleared2019: 4 descendants cleared2020: 4 descendants cleared2018: 3 descendants cleared2021: 3 descendants cleared2025: 11 descendants cleared2026: 9 descendants clearedK002592 · Interpore Cross Anterior Cervical Plate System · Interpore Cross Intl. · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 10 descendants5 generations forward: 17 descendants6 generations forward: 18 descendants7 generations forward: 8 descendants8 generations forward: 6 descendants9 generations forward: 4 descendants K002592 · Interpore Cross Anterior Cervical Plate System · Interpore Cross Intl. · 20000+5
  1. Root · 1 generation backK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
  2. This deviceK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
  3. Descendant · cites it directly · 57 of its ownK070285 Life Spine Anterior Cervical Plate SystemLife Spine · 2007
  4. Descendant · cites it directly · 53 of its ownK062643 Kinetic Anterior Cervical PlateLife Spine · 2006
  5. Descendant · 2 generations on · 52 of its ownK073479 Kinetic-SL Anterior Cervical Plate SystemLife Spine · 2008
  6. Descendant · 3 generations on · 51 of its ownK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
  7. Descendant · 2 generations on · 21 of its ownK130202 Iris Anterior Cervical PlateLife Spine, Inc. · 2013

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

2006: 22007: 12008: 12010: 22011: 22012: 32013: 22014: 32015: 22016: 32017: 22018: 32019: 42020: 42021: 32022: 62023: 52024: 92025: 112026: 9
2006high 11 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 77 · See all
  • K070285Life Spine Anterior Cervical Plate SystemLife Spine · 2007 · cites it directly57descendants
  • K062643Kinetic Anterior Cervical PlateLife Spine · 2006 · cites it directly53descendants
  • K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine · 2008 · 2 generations on52descendants
  • K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010 · 3 generations on51descendants
  • K130202Iris Anterior Cervical PlateLife Spine, Inc. · 2013 · 2 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002592Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl.2000—
0 (this device)K040844Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC2004—
+1K070285Life Spine Anterior Cervical Plate SystemLife Spine2007—
+1K062643Kinetic Anterior Cervical PlateLife Spine2006—
+2K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine2008—
+3K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.2010—
+2K130202Iris Anterior Cervical PlateLife Spine, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
200810
201020
201120
201230
201320
201430
201520
201630
201720
201830
201940
202040
202130
202260
202350
202490
2025110
202690
FIG. 1 — Lineage of K040844, 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K002592Interpore Cross Anterior Cervical Plate System
Summary page 1
…Device Trade Name: NEOTM Anterior Cervical Plate System 2. Predicate Devices Interpore Cross International Anterior Cervical Plate System (K002592) and the llowmedica Osteonics Corporation Reflex Anterior Cervical Plate System (K031702). 3. Intended Use The NEO Anterio…
Interpore Cross Intl.2000—
*K031702Reflex Anterior Cervical Plate System
Summary page 1
…cate Devices Interpore Cross International Anterior Cervical Plate System (K002592) and the llowmedica Osteonics Corporation Reflex Anterior Cervical Plate System (K031702). 3. Intended Use The NEO Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior s…
Howmedica Osteonics2003—

Also cleared against K002592: 1 other device →

What descends from it? (77)

See all 77

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

NumberDeviceApplicantDecidedDescendants
K070285Life Spine Anterior Cervical Plate SystemLife Spine200757
K062643Kinetic Anterior Cervical PlateLife Spine200653
K062831Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine200617
K110990Gso ACP1 Anterior Cervical Plate SystemGold Standard Orthopedics, LLC20110

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K070285 (Life Spine, 2007) has gone furthest, with 57 descendants of its own.
  • 1 other device also cites its predicate K002592.

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 NEOTM 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 confimled by patient history and radiographic studies); spondylolisthesis; trauma…

Read the full statement (115 words)

The NEOTM 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 confimled 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.

WARNING: This device is not approved 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 K002592

1 other device cites the same predicate.

  • K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007

More from Life Spine, LLC

2 FDA decisions under this applicant name. See the company

  • K133564Modification to Nautilus Spinal SystemLife Spine, LLC · 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/K040844 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040844: Life Spine Neo Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040844

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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