510(k) Report

510(k) · Cleared

Cleared

Altes Buttress Plating System

K061482510(k) TraditionalCleared Jul 26, 200657-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

Altiva Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jul 26, 2006 after a 57-day review. The FDA summary names no predicate by number. 6 later devices descend from it.

Decided
Jul 26, 2006
Review
57 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2018: 1 descendant cleared2008: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared20052010201520202025
  1. This deviceK061482 Altes Buttress Plating SystemAltiva Corp. · 2006
  2. Descendant · cites it directly · 2 of its ownK183214 Raven Lumbar Plate SystemChoicespine, LP · 2019
  3. Descendant · cites it directly · 1 of its ownK073349 Reliance Buttress Washer SystemReliance Medical Systems, LLC · 2008
  4. Descendant · 2 generations on · 0 of its ownK260015 ANTERIS Thoracolumbar Plate SystemSpineCraft · 2026
  5. Descendant · 2 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
  6. Descendant · 2 generations on · 0 of its ownK213219 Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12018: 12019: 12021: 12024: 12026: 1
2008high 1 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K183214Raven Lumbar Plate SystemChoicespine, LP · 2019 · cites it directly2descendants
  • K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC · 2008 · cites it directly1descendant
  • K260015ANTERIS Thoracolumbar Plate SystemSpineCraft · 2026 · 2 generations on0descendants
  • K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 2 generations on0descendants
  • K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K061482Altes Buttress Plating SystemAltiva Corp.2006—
+1K183214Raven Lumbar Plate SystemChoicespine, LP2019—
+1K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC2008—
+2K260015ANTERIS Thoracolumbar Plate SystemSpineCraft2026—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC2024—
+2K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201810
201910
202110
202410
202610
FIG. 1 — Lineage of K061482, 2006–2026Source: 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? (6)

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

NumberDeviceApplicantDecidedDescendants
K183214Raven Lumbar Plate SystemChoicespine, LP20192
K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC20081
K180537Zavation Buttress Plate SystemZavation Medical Products, LLC20180

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, K183214 (Choicespine, LP, 2019) has gone furthest, with 2 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?

The ALTES TM 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 interverbral 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.

Cite this page

510(k) Report. “K061482: Altes Buttress Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061482

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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