510(k) · Cleared
ClearedKiva VCF Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benvenue Medical, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Jan 24, 2014 as substantially equivalent to K063606 (Spine Wave, Inc., 2007) and 3 other predicates after a 137-day review. Its family tree reaches back 10 generations to 1997. 9 later devices descend from it.
- Decided
- Jan 24, 2014
- Review
- 137 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K970097 (1997). 59 ancestors in all, the oldest K803106 (1981). 9 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 6 generations between
- 3 generations backK040612 Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004
- 2 generations backK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- 1 generation backK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- This deviceK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK181262 SpineJack Expansion KitVexim SA · 2018
- Descendant · 2 generations on · 3 of its ownK202393 SpineJack Expansion KitStryker Corporation · 2020
- Descendant · 3 generations on · 2 of its ownK211238 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex…Stryker Instruments · 2021
- Descendant · cites it directly · 2 of its ownK191709 V-STRUT Vertebral ImplantHyprevention Sas · 2020
- Descendant · 4 generations on · 1 of its ownK223294 SpineJack® Expansion KitStryker Instruments · 2022
Show all 10 generations
- Root · 10 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 9 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 8 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 7 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
- 6 generations backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- 5 generations backK032358 B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd. · 2003
- 4 generations backK034037 Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd. · 2004
- 3 generations backK040612 Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004
- 2 generations backK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- 1 generation backK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- This deviceK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K181262SpineJack Expansion KitVexim SA · 2018 · cites it directly4descendants
- K202393SpineJack Expansion KitStryker Corporation · 2020 · 2 generations on3descendants
- K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments · 2021 · 3 generations on2descendants
- K191709V-STRUT Vertebral ImplantHyprevention Sas · 2020 · cites it directly2descendants
- K223294SpineJack® Expansion KitStryker Instruments · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −9 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −8 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −7 | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | 2002 | 1 |
| −6 | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| −5 | K032358 | B-Twin Bone Expander System (B-Twin BE System) | Disc-O-Tech Medical Technologies, Ltd. | 2003 | — |
| −4 | K034037 | Sky Bone Expander System | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| −3 | K040612 | Sky Bone Expander System (Sky System) | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| −2 | K053336 | Staxx FX System | Spine Wave, Inc. | 2006 | — |
| −1 | K063606 | Modification to Staxx FX System | Spine Wave, Inc. | 2007 | — |
| 0 (this device) | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +1 | K181262 | SpineJack Expansion Kit | Vexim SA | 2018 | — |
| +2 | K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020 | — |
| +3 | K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV… | Stryker Instruments | 2021 | — |
| +1 | K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | 2020 | — |
| +4 | K223294 | SpineJack® Expansion Kit | Stryker Instruments | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K063606 | Modification to Staxx FX SystemSummary page 2…Device Manufacturer 510(k) StaXxTM FX System SpineWave, Inc K063606 Benvenue VCF Osteo Coil System Benvenue Medical, Inc K070293 KyphX®D HV-RTM Bone Cement… | 2007 |
| * | K070293 | Benvenue VCF Osteo Coil SystemSummary page 2…M FX System SpineWave, Inc K063606 Benvenue VCF Osteo Coil System Benvenue Medical, Inc K070293 KyphX®D HV-RTM Bone Cement Kyphon, Inc. (Medtronic) K04 1584 KyphX® Inflatable Bone Tamp… | 2007 |
| * | K041584 | Kyphx HV-R Bone Cement, Model C01ASummary page 2…ue VCF Osteo Coil System Benvenue Medical, Inc K070293 KyphX®D HV-RTM Bone Cement Kyphon, Inc. (Medtronic) K04 1584 KyphX® Inflatable Bone Tamp Kyphon, Inc. (Medtronic) K010246 Device Description: The Kiva® VCF… | 2004 |
| * | K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3…Summary page 2…HV-RTM Bone Cement Kyphon, Inc. (Medtronic) K04 1584 KyphX® Inflatable Bone Tamp Kyphon, Inc. (Medtronic) K010246 Device Description: The Kiva® VCF Treatment System is provided as a sterile, single use, implantable device which may be use… | 2001 |
What descends from it? (9)
3 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 17 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 15 of the 59 ancestors have a recall of any class.
- Of its descendants, K181262 (Vexim SA, 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K063606.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Kiva® VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132817 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132817: Kiva VCF Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132817
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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