510(k) · Cleared
ClearedBenvenue VCF Osteo Coil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benvenue Medical, Inc. · OCJ Spinal Channeling Instrument, Vertebroplasty
Cleared on Jul 10, 2007 as substantially equivalent to K063248 (Medtronic Sofamor Danek, 2007) and 2 other predicates after a 160-day review. Its family tree reaches back 6 generations to 2001. 10 later devices descend from it.
- Decided
- Jul 10, 2007
- Review
- 160 days
- Class
- Class I
- Product code
- OCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K002652 (2001). 22 ancestors in all, the oldest K890925 (1989). 10 later devices descend from it, 1 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 deviceK070293 Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK181262 SpineJack Expansion KitVexim SA · 2018
- Descendant · 3 generations on · 3 of its ownK202393 SpineJack Expansion KitStryker Corporation · 2020
- Descendant · 4 generations on · 2 of its ownK211238 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex…Stryker Instruments · 2021
- Descendant · 2 generations on · 2 of its ownK191709 V-STRUT Vertebral ImplantHyprevention Sas · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · cites it directly9descendants
- K181262SpineJack Expansion KitVexim SA · 2018 · 2 generations on4descendants
- K202393SpineJack Expansion KitStryker Corporation · 2020 · 3 generations on3descendants
- K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments · 2021 · 4 generations on2descendants
- K191709V-STRUT Vertebral ImplantHyprevention Sas · 2020 · 2 generations on2descendants
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) | K070293 | Benvenue VCF Osteo Coil System | Benvenue Medical, Inc. | 2007 | — |
| +1 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +2 | K181262 | SpineJack Expansion Kit | Vexim SA | 2018 | — |
| +3 | K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020 | — |
| +4 | K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV… | Stryker Instruments | 2021 | — |
| +2 | K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K063248 | Arcuate Vertebral Augmentation System Cleared while this submission was under review Summary page 1…or status ARCUATE m Vertebral Augmentation System Medtronic Sofamor K063248 (ARC TM Osteotome instrument) Danek Radial Disc Cutter… | 2007 |
| * | K032891 | TRANS1 Trans-Sacral Spinal Access and Preparation KitSummary page 1…K063248 (ARC TM Osteotome instrument) Danek Radial Disc Cutter Transi, Inc K032891 Accessory within the Trans-sacral Spinal Access & Preparation Device Spineology Bone Reamer… | 2004 |
| * | K061154 | Kinsa Suture AnchorSummary page 1…Exempt KINSA Suture Anchor Smith & Nephew, Inc K061154 Device Description: The Benvenue VCF Osteo Coil System is packaged as a single-use, sterile, non-implantable device. It is… | 2006 |
| * | — | Spineology Bone Reamer Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132817 | Kiva VCF Treatment System | 2014 | 9 |
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.
- 7 of the 22 ancestors have a recall of any class.
- Of its descendants, K132817 (Benvenue Medical, Inc., 2014) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K063248.
How does its category compare?
All OCJ devicesOCJ Spinal Channeling Instrument, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OCJ
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · OCJ
Too few OCJ 510(k)s in any year since 2007 to give a median.
Recalls per year · OCJ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCJ
6in 2025
MAUDE reports naming product code OCJ, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Benvenue VCF Osteo Coil System is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070293 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070293: Benvenue VCF Osteo Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070293
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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