510(k) Report

510(k) · Cleared

Cleared

Interpore Cross Anterior Cervical Plate System

K002592510(k) TraditionalCleared Oct 6, 200046-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

Interpore Cross Intl. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Oct 6, 2000 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 88 later devices descend from it.

Decided
Oct 6, 2000
Review
46 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 2 descendants cleared2004: 1 descendant cleared2011: 3 descendants cleared2006: 2 descendants cleared2015: 6 descendants cleared2016: 3 descendants cleared2012: 4 descendants cleared2010: 3 descendants cleared2008: 1 descendant cleared2013: 2 descendants cleared2018: 3 descendants cleared2023: 6 descendants cleared2017: 3 descendants cleared2024: 9 descendants cleared2022: 6 descendants cleared2026: 9 descendants cleared2014: 3 descendants cleared2019: 4 descendants cleared2020: 4 descendants cleared2021: 3 descendants cleared2025: 11 descendants cleared200020052010201520202025
  1. This deviceK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
  2. Descendant · cites it directly · 77 of its ownK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
  3. Descendant · 2 generations on · 57 of its ownK070285 Life Spine Anterior Cervical Plate SystemLife Spine · 2007
  4. Descendant · 2 generations on · 53 of its ownK062643 Kinetic Anterior Cervical PlateLife Spine · 2006
  5. Descendant · 3 generations on · 52 of its ownK073479 Kinetic-SL Anterior Cervical Plate SystemLife Spine · 2008
  6. Descendant · 4 generations on · 51 of its ownK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010

Showing 5 of 88 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22007: 22008: 12010: 32011: 32012: 42013: 22014: 32015: 62016: 32017: 32018: 32019: 42020: 42021: 32022: 62023: 62024: 92025: 112026: 9
2004high 11 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 88 · See all
  • K040844Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004 · cites it directly77descendants
  • K070285Life Spine Anterior Cervical Plate SystemLife Spine · 2007 · 2 generations on57descendants
  • K062643Kinetic Anterior Cervical PlateLife Spine · 2006 · 2 generations on53descendants
  • K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine · 2008 · 3 generations on52descendants
  • K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010 · 4 generations on51descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002592Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl.2000—
+1K040844Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC2004—
+2K070285Life Spine Anterior Cervical Plate SystemLife Spine2007—
+2K062643Kinetic Anterior Cervical PlateLife Spine2006—
+3K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine2008—
+4K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200720
200810
201030
201130
201240
201320
201430
201560
201630
201730
201830
201940
202040
202130
202260
202360
202490
2025110
202690
FIG. 1 — Lineage of K002592, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (88)

See all 88

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

NumberDeviceApplicantDecidedDescendants
K040844Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC200477
K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.200738

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, K040844 (Life Spine, LLC, 2004) has gone furthest, with 77 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—

More from Interpore Cross Intl.

39 FDA decisions under this applicant name. See the company

  • K050861Peek CasInterpore Cross Intl. · 2005
  • K031399Intergro DBMInterpore Cross Intl. · 20051 recall
  • K041407Titanium Mesh ImplantInterpore Cross Intl. · 2004
  • K043229Modification to Altius Oct SystemInterpore Cross Intl. · 2004
  • K042798C-Tek C-Trun Anterior Cervical Plate SystemInterpore Cross Intl. · 2004

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
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  • 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/K002592 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002592: Interpore Cross Anterior 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/K002592

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026