510(k) Report

510(k) · Cleared

Cleared

Reliance Buttress Washer System

K073349510(k) TraditionalCleared Feb 13, 200876-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

Reliance Medical Systems, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Feb 13, 2008 as substantially equivalent to K970048 (Synthes (Usa), 1997) and 5 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.

Decided
Feb 13, 2008
Review
76 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K926453 (1993). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor2021: 1 descendant clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 1993K970048 · Synthes (Usa)Titanium Locking Plate System (Tilps) · Synthes (Usa) · 1997K040130 · Anterior Lumbar Buttress System · Seaspine · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant K040130 · Anterior Lumbar Buttress System · Seaspine · 2004K970048 · Synthes (Usa)Titanium Locking Plate System (Tilps) · Synthes (Usa) · 1997K926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930
  1. Root · 3 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. 2 generations backK970048 Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997
  3. 1 generation backK040130 Anterior Lumbar Buttress SystemSeaspine · 2004
  4. This deviceK073349 Reliance Buttress Washer SystemReliance Medical Systems, LLC · 2008
  5. Descendant · cites it directly · 0 of its ownK213219 Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC · 2021

Most influential descendants

Showing 1 of 1 · See all
  • K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
−2K970048Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa)1997—
−1K040130Anterior Lumbar Buttress SystemSeaspine2004—
0 (this device)K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC2008—
+1K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
200010
200110
200210
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K073349, 1993–2021Source: 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? (6)

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
*K970048Synthes (Usa)Titanium Locking Plate System (Tilps)
Summary page 1
…KWQ Substantial Equivalence The Reliance Buttress Washer is substantially equivalent to the legally marketed Synthes Titanium Locking Plate System (K970048), the Medtronic Sofamor Danek Bone Graft Washer (K994122, K041217), the DePuy BowTi Anterior Buttress Staple System (K021039), th…
Synthes (Usa)1997—
*K994122Bone Graft Washer, Model 9090114 - 9090118
Summary page 1
…iance Buttress Washer is substantially equivalent to the legally marketed Synthes Titanium Locking Plate System (K970048), the Medtronic Sofamor Danek Bone Graft Washer (K994122, K041217), the DePuy BowTi Anterior Buttress Staple System (K021039), the SeaSpine Anterior Lumbar Buttress System (K040130), and…
Danek Medical, Inc.2000—
*K041217Modification to Bone Graft Washer
Summary page 1
…tress Washer is substantially equivalent to the legally marketed Synthes Titanium Locking Plate System (K970048), the Medtronic Sofamor Danek Bone Graft Washer (K994122, K041217), the DePuy BowTi Anterior Buttress Staple System (K021039), the SeaSpine Anterior Lumbar Buttress System (K040130), and the Alti…
Medtronic Sofamor Danek, Inc.2004—
*K021039Bowti Anterior Buttress Staple System
Summary page 1
…keted Synthes Titanium Locking Plate System (K970048), the Medtronic Sofamor Danek Bone Graft Washer (K994122, K041217), the DePuy BowTi Anterior Buttress Staple System (K021039), the SeaSpine Anterior Lumbar Buttress System (K040130), and the Altiva ALTESTmAnterior Buttress Plating System (K061482). The R…
Depuyacromed2002—
*K040130Anterior Lumbar Buttress System
Summary page 1
…he Medtronic Sofamor Danek Bone Graft Washer (K994122, K041217), the DePuy BowTi Anterior Buttress Staple System (K021039), the SeaSpine Anterior Lumbar Buttress System (K040130), and the Altiva ALTESTmAnterior Buttress Plating System (K061482). The Reliance Buttress Washer is equivalent to these commercia…
Seaspine2004—
*K061482Altes Buttress Plating System
Summary page 1
…he DePuy BowTi Anterior Buttress Staple System (K021039), the SeaSpine Anterior Lumbar Buttress System (K040130), and the Altiva ALTESTmAnterior Buttress Plating System (K061482). The Reliance Buttress Washer is equivalent to these commercially available devices in terms of material, intended use, levels o…
Altiva Corp.2006—

Also cleared against K970048: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC20210

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?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K213219 (Vy Spine, LLC, 2021) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K970048.

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 Reliance Buttress Washer System is intended to stabilize the bone graft at one level (TI-S 1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Indications for use as stated in the FDA summary.

Also cleared against K970048

6 other devices cite the same predicate.

  • K170530Butrex Lumbar Buttress Plating SystemX-Spine Systems, Inc. · 2017
  • K081418Spinal Elements Buttress Plate SystemSpinal Elements, Inc. · 2008
  • K040130Anterior Lumbar Buttress SystemSeaspine · 2004
  • K012881C3 Anterior Cervical Plate SystemSpine Vision, Inc. · 2001
  • K010466Tether AcfsTheken Surgical,Llc · 2001
  • K994383Dogbone AcfsTheken Surgical · 2000

More from Reliance Medical Systems, LLC

24 FDA decisions under this applicant name. See the company

  • K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2022
  • K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2021
  • K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2019
  • K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2018
  • K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC · 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/K073349 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073349: Reliance Buttress Washer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073349

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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