510(k) Report

510(k) · Cleared

Cleared

Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax Vertebral Balloon System, 11G

K131820510(k) TraditionalCleared Oct 4, 2013106-day reviewClass II21 CFR 888.1100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Care Fusion · HRX Arthroscope

Cleared on Oct 4, 2013 as substantially equivalent to K103064 (Care Fusion, 2011) and 3 other predicates after a 106-day review. Its family tree reaches back 5 generations to 1998. 8 later devices descend from it.

Decided
Oct 4, 2013
Review
106 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K981251 (1998). 9 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor2016: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2024: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant clearedK981251 · Kyphon Inflatable Bone Tamp · Kyphon, Inc. · 1998 · recalledK032212 · Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A · Kyphon, Inc. · 2003K041454 · Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A · Kyphon, Inc. · 2004 · recalledK090211 · Inflatable Bone Tamp · Cardinal Health, Inc. · 2009K093463 · Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 · Care Fusion · 20101995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K093463 · Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 · Care Fusion · 2010K090211 · Inflatable Bone Tamp · Cardinal Health, Inc. · 2009K041454 · Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A · Kyphon, Inc. · 2004 · recalledK032212 · Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A · Kyphon, Inc. · 2003K981251 · Kyphon Inflatable Bone Tamp · Kyphon, Inc. · 1998 · recalled−50
  1. Root · 5 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
  2. 4 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
  3. 3 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
  4. 2 generations backK090211 Inflatable Bone TampCardinal Health, Inc. · 2009
  5. 1 generation backK093463 Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010
  6. This deviceK131820 Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon…Care Fusion · 2013
  7. Descendant · cites it directly · 4 of its ownK151704 Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016
  8. Descendant · 2 generations on · 2 of its ownK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
  9. Descendant · 3 generations on · 1 of its ownK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
  10. Descendant · cites it directly · 1 of its ownK150523 AVAmax Vertebral BalloonCare Fusion · 2015
  11. Descendant · 3 generations on · 0 of its ownK251719 Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12016: 22019: 12023: 12024: 12025: 1
2014high 2 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 8 · See all
  • K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016 · cites it directly4descendants
  • K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019 · 2 generations on2descendants
  • K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA · 2023 · 3 generations on1descendant
  • K150523AVAmax Vertebral BalloonCare Fusion · 2015 · cites it directly1descendant
  • K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K981251Kyphon Inflatable Bone TampKyphon, Inc.19983
−4K032212Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc.2003—
−3K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc.20045
−2K090211Inflatable Bone TampCardinal Health, Inc.2009—
−1K093463Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion2010—
0 (this device)K131820Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G…Care Fusion2013—
+1K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH2016—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA2019—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement…Ulrich Medical USA2023—
+1K150523AVAmax Vertebral BalloonCare Fusion2015—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200510
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201620
201910
202310
202410
202510
FIG. 1 — Lineage of K131820, 1998–2025Source: 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 HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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? (4)

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
*K103064Avamax Vertebral Balloon
Summary page 1
…15, VBTO82O, VBIT1O10, VBT10O15, VBT1 020, VETi1115. VBT1 120 Legally marketed CareFusion Inflatable Bone Tamps, K103064, K093463. K09021 1, device(s) to which Radiopaque Bone Cement, K043518 equivalence is claimed Reason for 51 0(k…
Care Fusion2011—
*K093463Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020
Summary page 1
…2O, VBIT1O10, VBT10O15, VBT1 020, VETi1115. VBT1 120 Legally marketed CareFusion Inflatable Bone Tamps, K103064, K093463. K09021 1, device(s) to which Radiopaque Bone Cement, K043518 equivalence is claimed Reason for 51 0(k)…
Care Fusion2010—
*K090211Inflatable Bone Tamp
Summary page 1
…O10, VBT10O15, VBT1 020, VETi1115. VBT1 120 Legally marketed CareFusion Inflatable Bone Tamps, K103064, K093463. K09021 1, device(s) to which Radiopaque Bone Cement, K043518 equivalence is claimed Reason for 51 0(k)…
Cardinal Health, Inc.2009—
*K043518Radiopaque Bone Cement
Summary page 1
…VBT1 120 Legally marketed CareFusion Inflatable Bone Tamps, K103064, K093463. K09021 1, device(s) to which Radiopaque Bone Cement, K043518 equivalence is claimed Reason for 51 0(k) Modifications to Device submission Device description…
Cardinalhealth2005—

Also cleared against K103064: 3 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164
K150523AVAmax Vertebral BalloonCare Fusion20151
K141419ZvplastyZavation, LLC20140

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 3.6 years on median.
  • 4 of the 9 ancestors have a recall of any class.
  • Of its descendants, K151704 (Signus Medizintechnik GmbH, 2016) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K103064.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

What is it indicated for?

Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).

Indications for use as stated in the FDA summary.

Also cleared against K103064

3 other devices cite the same predicate.

  • K200763Osteo-site Vertebral BalloonIzi Medical · 2020
  • K131824Avaflex Vertebral Balloon SystemCare Fusion · 2013
  • K122533Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc. · 2012

More from Care Fusion

34 FDA decisions under this applicant name. See the company

  • K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceCare Fusion · 2024
  • K231888BD Texium™ Needle-Free SyringeCare Fusion · 2023
  • K221327BD Alaris™ Pump Infusion SetsCare Fusion · 2023
  • K221319BD Alaris™ Pump Epidural Infusion SetCare Fusion · 2023
  • K223101BD Secondary Infusion SetCare Fusion · 2023

Recent decisions in HRX

The HRX category page

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026

https://510kreport.com/device/K131820 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131820: Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax Vertebral Balloon System, 11G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131820

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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