# K070293: Benvenue VCF Osteo Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Benvenue Medical, Inc.
- Decided: Jul 10, 2007 after 160 days
- Product code: OCJ (Spinal Channeling Instrument, Vertebroplasty)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002652 (2001). 22 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063248: Arcuate Vertebral Augmentation System, Medtronic Sofamor Danek (2007). Cleared while this submission was under review Summary page 1.
- K032891: TRANS1 Trans-Sacral Spinal Access and Preparation Kit, Trans1, Inc. (2004) Summary page 1.
- K061154: Kinsa Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 1.
- (no number) Spineology Bone Reamer: named in the summary without a submission number

## Most influential descendants
- K132817: Kiva VCF Treatment System (2014), 9 descendants of its own
- K181262: SpineJack Expansion Kit (2018), 4 descendants of its own
- K202393: SpineJack Expansion Kit (2020), 3 descendants of its own
- K211238: SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement (2021), 2 descendants of its own
- K191709: V-STRUT Vertebral Implant (2020), 2 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K070293
Methodology: https://510kreport.com/methodology