510(k) Report

510(k) · Cleared

Cleared

Bone Graft Washer, Model 9090114 - 9090118

K994122510(k) TraditionalCleared Feb 18, 200073-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

Danek Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Feb 18, 2000 after a 73-day review. The FDA summary names no predicate by number. 251 later devices descend from it.

Decided
Feb 18, 2000
Review
73 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 2 descendants cleared2002: 2 descendants cleared2013: 4 descendants cleared2005: 3 descendants cleared2009: 2 descendants cleared2006: 3 descendants cleared2007: 2 descendants cleared2017: 4 descendants cleared2020: 22 descendants cleared2021: 17 descendants cleared2010: 2 descendants cleared2023: 35 descendants cleared2012: 3 descendants cleared2018: 8 descendants cleared2011: 1 descendant cleared2019: 15 descendants cleared2014: 1 descendant cleared2016: 2 descendants cleared2022: 28 descendants cleared2026: 36 descendants cleared2024: 29 descendants cleared2015: 2 descendants cleared2025: 28 descendants cleared200020052010201520202025
  1. This deviceK994122 Bone Graft Washer, Model 9090114 - 9090118Danek Medical, Inc. · 2000
  2. Descendant · cites it directly · 248 of its ownK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  3. Descendant · 2 generations on · 211 of its ownK052546 Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006
  4. Descendant · 2 generations on · 211 of its ownK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
  5. Descendant · 3 generations on · 165 of its ownK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
  6. Descendant · 2 generations on · 161 of its ownK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007

Showing 5 of 251 descendants. See all descendants

Descendants cleared per year

2002: 22005: 32006: 32007: 22008: 22009: 22010: 22011: 12012: 32013: 42014: 12015: 22016: 22017: 42018: 82019: 152020: 222021: 172022: 282023: 352024: 292025: 282026: 36
2002high 36 (2026) · low 0 (2003)2026

Most influential descendants

Showing 5 of 251 · See all
  • K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002 · cites it directly248descendants
  • K052546Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006 · 2 generations on211descendants
  • K043548Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005 · 2 generations on211descendants
  • K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006 · 3 generations on165descendants
  • K070922Modification to Spinal Usa VBR SystemSpinal USA · 2007 · 2 generations on161descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994122Bone Graft Washer, Model 9090114 - 9090118Danek Medical, Inc.2000—
+1K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002—
+2K052546Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc.2006—
+2K043548Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc.2005—
+3K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc.2006—
+2K070922Modification to Spinal Usa VBR SystemSpinal USA2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200530
200630
200720
200820
200920
201020
201110
201230
201340
201410
201520
201620
201740
201880
2019150
2020220
2021170
2022280
2023350
2024290
2025280
2026360
FIG. 1 — Lineage of K994122, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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?

The FDA summary names no predicate by number.

What descends from it? (251)

See all 251

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

NumberDeviceApplicantDecidedDescendants
K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002248
K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC20081

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, K013665 (Medtronic Sofamor Danek, Inc., 2002) has gone furthest, with 248 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—

What is it indicated for?

Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Danek Medical, Inc.

56 FDA decisions under this applicant name. See the company

  • K993810CD Horizon Spinal SystemDanek Medical, Inc. · 2000
  • K993855Atlantis Anterior Cervical Plate SystemDanek Medical, Inc. · 1999
  • K991528Modification to Tenor Spinal System-Rod/Bolt ConnectorDanek Medical, Inc. · 1999
  • K990603Modification of the Zplate-Atl Anterior Fixation SystemDanek Medical, Inc. · 1999
  • K982875Modification to Zplate-Atl Anterior Fixation SystemDanek Medical, Inc. · 1999

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/K994122 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994122: Bone Graft Washer, Model 9090114 - 9090118.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994122

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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