510(k) · Cleared
ClearedV-STRUT Vertebral Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyprevention Sas · NDN Cement, Bone, Vertebroplasty
Cleared on Mar 5, 2020 as substantially equivalent to K132817 (Benvenue Medical, Inc., 2014) after a 253-day review. Its family tree reaches back 11 generations to 1997. 2 later devices descend from it.
- Decided
- Mar 5, 2020
- Review
- 253 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K970097 (1997). 60 ancestors in all, the oldest K803106 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 7 generations between
- 3 generations backK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- 2 generations backK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- 1 generation backK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- This deviceK191709 V-STRUT Vertebral ImplantHyprevention Sas · 2020
- Descendant · cites it directly · 0 of its ownK240084 V-STRUT® Vertebral ImplantHyprevention · 2024
- Descendant · cites it directly · 0 of its ownK221697 Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC · 2023
Show all 11 generations
- Root · 11 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 10 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 9 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 8 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
- 7 generations backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- 6 generations backK032358 B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd. · 2003
- 5 generations backK034037 Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd. · 2004
- 4 generations backK040612 Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004
- 3 generations backK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- 2 generations backK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- 1 generation backK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- This deviceK191709 V-STRUT Vertebral ImplantHyprevention Sas · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −10 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −9 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −8 | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | 2002 | 1 |
| −7 | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| −6 | K032358 | B-Twin Bone Expander System (B-Twin BE System) | Disc-O-Tech Medical Technologies, Ltd. | 2003 | — |
| −5 | K034037 | Sky Bone Expander System | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| −4 | K040612 | Sky Bone Expander System (Sky System) | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| −3 | K053336 | Staxx FX System | Spine Wave, Inc. | 2006 | — |
| −2 | K063606 | Modification to Staxx FX System | Spine Wave, Inc. | 2007 | — |
| −1 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| 0 (this device) | K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | 2020 | — |
| +1 | K240084 | V-STRUT® Vertebral Implant | Hyprevention | 2024 | — |
| +1 | K221697 | Injection Pin (Kip (02031-02061) (03031-03061)) | Slk Ortho, LLC | 2023 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K132817 | Kiva VCF Treatment SystemSummary page 4…PMMA) bone cement Regulatory Class: II Product Code: NDN LOD III. PREDICATE DEVICE Primary predicate: KIVA® VCF Treatment System (K132817) Reference Device/Clinical comparators: F20® (K103433), CORTOSS® Bone Augmentation Material (K08010… | 2014 |
| † | K103433 | F20 | 2011 |
| † | K080108 | Cortoss Bone Augmentation Material | 2009 |
What descends from it? (2)
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 23 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 15 of the 60 ancestors have a recall of any class.
- Of its descendants, K240084 (Hyprevention, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132817.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with Teknimed F20® bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191709 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191709: V-STRUT Vertebral Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191709
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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