510(k) Report

510(k) · Cleared

Cleared

Bowti Anterior Buttress Staple System

K021039510(k) TraditionalCleared Dec 11, 2002254-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

Depuyacromed · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 11, 2002 as substantially equivalent to K010911 (Macropore Biosurgery, Inc., 2001) after a 254-day review. Its family tree reaches back 1 generation to 2001. 32 later devices descend from it.

Decided
Dec 11, 2002
Review
254 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K010911 (2001). 32 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2008: 3 descendants cleared2014: 1 descendant cleared2019: 1 descendant cleared2004: 2 descendants cleared2007: 3 descendants cleared2005: 1 descendant cleared2009: 1 descendant cleared2021: 2 descendants cleared2020: 1 descendant cleared2017: 1 descendant cleared2026: 3 descendants cleared2023: 4 descendants cleared2022: 1 descendant cleared2025: 2 descendants cleared2024: 4 descendants clearedK010911 · Macropore OS Spinal System · Macropore Biosurgery, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 9 descendants3 generations forward: 5 descendants4 generations forward: 8 descendants5 generations forward: 2 descendants K010911 · Macropore OS Spinal System · Macropore Biosurgery, Inc. · 20010+5
  1. Root · 1 generation backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
  2. This deviceK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
  3. Descendant · cites it directly · 16 of its ownK133911 Genesys Spine Anterior Buttress Plate SystemGenesys Spine · 2014
  4. Descendant · 2 generations on · 14 of its ownK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
  5. Descendant · 3 generations on · 6 of its ownK202495 SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
  6. Descendant · 3 generations on · 5 of its ownK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
  7. Descendant · cites it directly · 4 of its ownK041105 Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2004: 22005: 12007: 32008: 32009: 12014: 12015: 22017: 12019: 12020: 12021: 22022: 12023: 42024: 42025: 22026: 3
2004high 4 (2023) · low 0 (2006)2026

Most influential descendants

Showing 5 of 32 · See all
  • K133911Genesys Spine Anterior Buttress Plate SystemGenesys Spine · 2014 · cites it directly16descendants
  • K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020 · 2 generations on14descendants
  • K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021 · 3 generations on6descendants
  • K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023 · 3 generations on5descendants
  • K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004 · cites it directly4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010911Macropore OS Spinal SystemMacropore Biosurgery, Inc.2001—
0 (this device)K021039Bowti Anterior Buttress Staple SystemDepuyacromed2002—
+1K133911Genesys Spine Anterior Buttress Plate SystemGenesys Spine2014—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC2020—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC2021—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical2023—
+1K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200510
200730
200830
200910
201410
201520
201710
201910
202010
202120
202210
202340
202440
202520
202630
FIG. 1 — Lineage of K021039, 2001–2026Source: 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? (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
*K010911Macropore OS Spinal SystemMacropore Biosurgery, Inc.2001—

Also cleared against K010911: 7 other devices →

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K133911Genesys Spine Anterior Buttress Plate SystemGenesys Spine201416
K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc.20044
K040130Anterior Lumbar Buttress SystemSeaspine20044
K062181C-Jaws Cervical Compressive Mini FrameMedicrea Technologies20073
K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated20151
K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC20081
K061385Osstaple, Ossplate, OssforceBiomedical Enterprises, Inc.20071
K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190

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?

  • Its one ancestor has no recall.
  • Of its descendants, K133911 (Genesys Spine, 2014) has gone furthest, with 16 descendants of its own.
  • 7 other devices also cite its predicate K010911.

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 BowTi Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

Indications for use as stated in the FDA summary.

Also cleared against K010911

7 other devices cite the same predicate.

  • K090415Eminent Spine Buttress (Fang) Plate SystemEminent Spine · 20091 recall
  • K081770Black Widow Anterior Buttress PlateOmni Surgical, L.P. · 20092 recalls
  • K071810Inion Spinal Graft Containment SystemInion, Ltd. · 2008
  • K062181C-Jaws Cervical Compressive Mini FrameMedicrea Technologies · 2007
  • K051821Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005
  • K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004

More from Depuyacromed

48 FDA decisions under this applicant name. See the company

  • K040197Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  • K031635Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030833Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  • K030249Surgical Titanium Mesh SystemDepuyacromed · 2003

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/K021039 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021039: Bowti Anterior Buttress Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021039

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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