510(k) · Cleared
ClearedAvaflex Vertebral Augmentation Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Nov 20, 2007 as substantially equivalent to K063248 (Medtronic Sofamor Danek, 2007) after a 110-day review. Its family tree reaches back 6 generations to 2001. 3 later devices descend from it.
- Decided
- Nov 20, 2007
- Review
- 110 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002652 (2001). 16 ancestors in all, the oldest K890925 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 5 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 4 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 3 generations backK042415 Mendec SpineTecres S.P.A. · 2005
- 2 generations backK062452 Kit Mendec Spine and Delivery SystemTecres S.P.A. · 2006
- 1 generation backK063248 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
- This deviceK072133 Avaflex Vertebral Augmentation NeedleCardinal Health, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK100479 Parallax Contour Vertebral Augmentation DeviceArthrocare Corp. · 2010
- Descendant · cites it directly · 0 of its ownK130402 Spider System Kolibri Cement NeedleSintea Plustek, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK110183 Arthrocare Parallax Contour Vertebral Augmentation DeviceArthrocare Corp. · 2011
Most influential descendants
Showing 3 of 3 · See all- K100479Parallax Contour Vertebral Augmentation DeviceArthrocare Corp. · 2010 · cites it directly1descendant
- K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC · 2013 · cites it directly0descendants
- K110183Arthrocare Parallax Contour Vertebral Augmentation DeviceArthrocare Corp. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −5 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −4 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −3 | K042415 | Mendec Spine | Tecres S.P.A. | 2005 | — |
| −2 | K062452 | Kit Mendec Spine and Delivery System | Tecres S.P.A. | 2006 | — |
| −1 | K063248 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | 2007 | — |
| 0 (this device) | K072133 | Avaflex Vertebral Augmentation Needle | Cardinal Health, Inc. | 2007 | — |
| +1 | K100479 | Parallax Contour Vertebral Augmentation Device | Arthrocare Corp. | 2010 | — |
| +1 | K130402 | Spider System Kolibri Cement Needle | Sintea Plustek, LLC | 2013 | — |
| +2 | K110183 | Arthrocare Parallax Contour Vertebral Augmentation Device | Arthrocare Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 NDN? 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 NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K063248 | Arcuate Vertebral Augmentation SystemSummary page 1…de Curette, Class Iexempt Medtronic Sofamor Danek, Arcuate Vertebral Augmentation System, K063248 II J Descript… | 2007 |
| * | — | Cardinal Health Chroma-Line Cervical and Lumbar Spine Curettes Named without a submission number | |
| * | — | Kyphon, Inc., Kyphx Latitude Curette Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K100479 (Arthrocare Corp., 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K063248.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, 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 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AVAflex Vertebral Augmentation Needle is used during a vertebroplasty to fill a fractured vertebral body with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma. The AVAflex Vertebral Augmentation Needle is used during a kyphoplasty tc scrape and score bone in the spine to create a void…
Read the full statement (105 words)
The AVAflex Vertebral Augmentation Needle is used during a vertebroplasty to fill a fractured vertebral body with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
The AVAflex Vertebral Augmentation Needle is used during a kyphoplasty tc scrape and score bone in the spine to create a void within a fractured vertebral body and fill the void with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072133: Avaflex Vertebral Augmentation Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072133
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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