510(k) Report

510(k) · Cleared

Cleared

Modification to Centaur Spinal System

K001844510(k) SpecialCleared Jul 19, 200030-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

Howmedica Osteonics Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jul 19, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 103 later devices descend from it.

Decided
Jul 19, 2000
Review
30 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

103 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2008: 2 descendants cleared2014: 1 descendant cleared2009: 1 descendant cleared2019: 7 descendants cleared2023: 20 descendants cleared2024: 16 descendants cleared2018: 4 descendants cleared2020: 4 descendants cleared2022: 11 descendants cleared2013: 1 descendant cleared2026: 16 descendants cleared2021: 6 descendants cleared2025: 13 descendants cleared200020052010201520202025
  1. This deviceK001844 Modification to Centaur Spinal SystemHowmedica Osteonics Corp. · 2000
  2. Descendant · cites it directly · 102 of its ownK073437 Thor Anterior Plating SystemStryker Spine · 2008 · Recalled
  3. Descendant · cites it directly · 101 of its ownK080773 Thor Anterior Plating SystemStryker Spine · 2008
  4. Descendant · 2 generations on · 73 of its ownK091253 Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model…K2m, Inc. · 2009
  5. Descendant · 3 generations on · 72 of its ownK131533 Cayman MI Plate SystemK2m, Inc. · 2013
  6. Descendant · 4 generations on · 52 of its ownK172941 CASCADIA Interbody SystemK2m · 2018

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2008: 22009: 12013: 12014: 12015: 12018: 42019: 72020: 42021: 62022: 112023: 202024: 162025: 132026: 16
2008high 20 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 103 · See all
  • K073437Thor Anterior Plating SystemStryker Spine · 2008 · cites it directly102descendants
  • K080773Thor Anterior Plating SystemStryker Spine · 2008 · cites it directly101descendants
  • K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc. · 2009 · 2 generations on73descendants
  • K131533Cayman MI Plate SystemK2m, Inc. · 2013 · 3 generations on72descendants
  • K172941CASCADIA Interbody SystemK2m · 2018 · 4 generations on52descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001844Modification to Centaur Spinal SystemHowmedica Osteonics Corp.2000—
+1K073437Thor Anterior Plating SystemStryker Spine200831
+1K080773Thor Anterior Plating SystemStryker Spine2008—
+2K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral…K2m, Inc.2009—
+3K131533Cayman MI Plate SystemK2m, Inc.2013—
+4K172941CASCADIA Interbody SystemK2m2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200910
201310
201410
201510
201840
201970
202040
202160
2022110
2023200
2024160
2025130
2026160
FIG. 1 — Lineage of K001844, 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? (103)

See all 103

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

NumberDeviceApplicantDecidedDescendants
K073437Thor Anterior Plating SystemStryker Spine2008102
K080773Thor Anterior Plating SystemStryker Spine2008101
K142699LITe Plate SystemStryker Corporation201446
K150449LITe Plate SystemStryker Corp.201524

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, K073437 (Stryker Spine, 2008) has gone furthest, with 102 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—
Cite this page

510(k) Report. “K001844: Modification to Centaur Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001844

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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