510(k) · Cleared
ClearedAcu-Cut Vertebral Augmentation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascendx Spine, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Feb 17, 2012 as substantially equivalent to K070527 (Medtronic Sofamor Danek, 2007) after an 88-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Feb 17, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K002652 (2001). 19 ancestors in all, the oldest K890925 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 6 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 5 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 4 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
- 3 generations backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
- 2 generations backK062424 Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006
- 1 generation backK070527 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
- This deviceK113452 Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −6 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −5 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −4 | K042691 | Vertefix Vertebroplasty Procedure Set | Cook, Inc. | 2005 | — |
| −3 | K060300 | Confidence High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | 8 |
| −2 | K062424 | Confidence EX High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | — |
| −1 | K070527 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | 2007 | — |
| 0 (this device) | K113452 | Acu-Cut Vertebral Augmentation System | Ascendx Spine, Inc. | 2012 | — |
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 | 2 | 0 |
| 2007 | 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? (1)
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 |
|---|---|---|---|
| * | K070527 | Arcuate Vertebral Augmentation SystemSummary page 1…Acu-Cut Vertebral Augmentation System Classification Name Vertebroplasty, Cement, Bone Predicate Devices Medtronic USA, Inc.’s Arcuate Vertebral Augmentation System (K070527) Intended Use / Indications for Use The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful patholo… | 2007 |
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 11 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 6 of the 19 ancestors have a recall of any class.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113452 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113452: Acu-Cut Vertebral Augmentation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113452
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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