510(k) · Cleared
ClearedArcuate Vertebral Augmentation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · NDN Cement, Bone, Vertebroplasty
Cleared on Mar 13, 2007 as substantially equivalent to K040483 (Medtronic Sofamor Danek, Inc., 2004) and 3 other predicates after a 138-day review. Its family tree reaches back 5 generations to 2001. 17 later devices descend from it.
- Decided
- Mar 13, 2007
- Review
- 138 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K002652 (2001). 15 ancestors in all, the oldest K890925 (1989). 17 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 4 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 3 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 2 generations backK042415 Mendec SpineTecres S.P.A. · 2005
- 1 generation backK062452 Kit Mendec Spine and Delivery SystemTecres S.P.A. · 2006
- This deviceK063248 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 10 of its ownK070293 Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007
- Descendant · 2 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK181262 SpineJack Expansion KitVexim SA · 2018
- Descendant · 4 generations on · 3 of its ownK202393 SpineJack Expansion KitStryker Corporation · 2020
- Descendant · cites it directly · 3 of its ownK072133 Avaflex Vertebral Augmentation NeedleCardinal Health, Inc. · 2007
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007 · cites it directly10descendants
- K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 2 generations on9descendants
- K181262SpineJack Expansion KitVexim SA · 2018 · 3 generations on4descendants
- K202393SpineJack Expansion KitStryker Corporation · 2020 · 4 generations on3descendants
- K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc. · 2007 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −4 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −3 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −2 | K042415 | Mendec Spine | Tecres S.P.A. | 2005 | — |
| −1 | K062452 | Kit Mendec Spine and Delivery System | Tecres S.P.A. | 2006 | — |
| 0 (this device) | K063248 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K070293 | Benvenue VCF Osteo Coil System | Benvenue Medical, Inc. | 2007 | — |
| +2 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +3 | K181262 | SpineJack Expansion Kit | Vexim SA | 2018 | — |
| +4 | K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020 | — |
| +1 | K072133 | Avaflex Vertebral Augmentation Needle | Cardinal Health, Inc. | 2007 | — |
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 |
|---|---|---|
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040483 | Equestra Fluid Delivery SystemSummary page 1…TM System to be substantially equivalent to previously cleared systems such as the EQUESTlRA Fluid Delivery System, (K040483, SE 06/23/04), the Kit Mendec Spine and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System… | 2004 |
| * | K062452 | Kit Mendec Spine and Delivery SystemSummary page 1…nt to previously cleared systems such as the EQUESTlRA Fluid Delivery System, (K040483, SE 06/23/04), the Kit Mendec Spine and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System (K060148, SE 03/13/06) and the Vertefix TM Vertebroplasty Procedure… | 2006 |
| * | K060148 | Ebi Vertebroplasty SystemsSummary page 1…Fluid Delivery System, (K040483, SE 06/23/04), the Kit Mendec Spine and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System (K060148, SE 03/13/06) and the Vertefix TM Vertebroplasty Procedure Set, Cook Incorporated (K042691, SE 11/08/05). The VIS… | 2006 |
| * | K042691 | Vertefix Vertebroplasty Procedure SetSummary page 2…res SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System (K060148, SE 03/13/06) and the Vertefix TM Vertebroplasty Procedure Set, Cook Incorporated (K042691, SE 11/08/05). The VISIOPLASTrM Spine Cement packaged with this system was cleared by the agency for use in the treatment of vert… | 2005 |
| † | K042415 | Mendec Spine | 2005 |
What descends from it? (17)
See all 173 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 4 companies; a new generation was cleared every 11 months on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K070293 (Benvenue Medical, Inc., 2007) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K040483.
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 ARCUATE 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063248 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063248: Arcuate Vertebral Augmentation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063248
Report an extraction error
Are you the manufacturer?
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