510(k) · Cleared
ClearedAVAmax Vertebral Balloon, AVAflex Vertebral Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · HRX Arthroscope
Cleared on Nov 1, 2016 as substantially equivalent to K150523 (Care Fusion, 2015) and 1 other predicate after a 98-day review. Its family tree reaches back 7 generations to 1998.
- Decided
- Nov 1, 2016
- Review
- 98 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K981251 (1998). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 6 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 5 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 4 generations backK090211 Inflatable Bone TampCardinal Health, Inc. · 2009
- 3 generations backK093463 Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010
- 2 generations backK131820 Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon…Care Fusion · 2013
- 1 generation backK150523 AVAmax Vertebral BalloonCare Fusion · 2015
- This deviceK162062 AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −6 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −5 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −4 | K090211 | Inflatable Bone Tamp | Cardinal Health, Inc. | 2009 | — |
| −3 | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | Care Fusion | 2010 | — |
| −2 | K131820 | Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G… | Care Fusion | 2013 | — |
| −1 | K150523 | AVAmax Vertebral Balloon | Care Fusion | 2015 | — |
| 0 (this device) | K162062 | AVAmax Vertebral Balloon, AVAflex Vertebral Balloon | Stryker Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
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 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150523 | AVAmax Vertebral BalloonSummary page 5…: HRX – Arthroscope Secondary Product Code: NDN – Cement, Bone, Vertebroplasty Predicate Devices: AVAmax Vertebral Balloon (K150523) AVAflex Vertebral Balloon (K151125) Indication for Use: The AVAmax Vertebral Balloon System… | 2015 |
| * | K151125 | AVAflex Vertebral Balloon SystemSummary page 5…DN – Cement, Bone, Vertebroplasty Predicate Devices: AVAmax Vertebral Balloon (K150523) AVAflex Vertebral Balloon (K151125) Indication for Use: The AVAmax Vertebral Balloon System (system) is intended for the reduction of fractures and/or creation of a… | 2015 |
| † | K080108 | Cortoss Bone Augmentation Material | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 13 ancestors have a recall of any class.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The AVAmax Vertebral Balloon System (system) is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. The AVAflex Vertebral…
Read the full statement (115 words)
The AVAmax Vertebral Balloon System (system) is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
The AVAflex Vertebral Balloon System (system) is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162062: AVAmax Vertebral Balloon, AVAflex Vertebral Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162062
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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