510(k) Report

510(k) · Cleared

Cleared

Butrex Buttress Plating System

K072943510(k) TraditionalCleared Jan 28, 2008103-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

X-Spine Systems, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 28, 2008 after a 103-day review. The FDA summary names no predicate by number. 20 later devices descend from it.

Decided
Jan 28, 2008
Review
103 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

20 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2014: 1 descendant cleared2017: 2 descendants cleared2020: 1 descendant cleared2026: 3 descendants cleared2023: 4 descendants cleared2021: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants cleared2024: 4 descendants cleared20052010201520202025
  1. This deviceK072943 Butrex Buttress Plating SystemX-Spine Systems, Inc. · 2008
  2. Descendant · cites it directly · 16 of its ownK133911 Genesys Spine Anterior Buttress Plate SystemGenesys Spine · 2014
  3. Descendant · 2 generations on · 14 of its ownK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
  4. Descendant · 3 generations on · 6 of its ownK202495 SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
  5. Descendant · 3 generations on · 5 of its ownK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
  6. Descendant · 3 generations on · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 22020: 12021: 12022: 12023: 42024: 42025: 22026: 3
2014high 4 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 20 · 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
  • K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072943Butrex Buttress Plating SystemX-Spine Systems, Inc.2008—
+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—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and…Corelink, LLC2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201720
202010
202110
202210
202340
202440
202520
202630
FIG. 1 — Lineage of K072943, 2008–2026Source: 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
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K133911Genesys Spine Anterior Buttress Plate SystemGenesys Spine201416
K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated20151
K170530Butrex Lumbar Buttress Plating SystemX-Spine Systems, Inc.20170

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, K133911 (Genesys Spine, 2014) has gone furthest, with 16 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. 2008, this device’s year, is highlighted.

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 Butrex Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

Indications for use as stated in the FDA summary.

More from X-Spine Systems, Inc.

34 FDA decisions under this applicant name. See the company

  • K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 20181 recall
  • K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
  • K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 20171 recall
  • K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 20171 recall
  • K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017

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/K072943 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072943: Butrex Buttress Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072943

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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