# K072133: Avaflex Vertebral Augmentation Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Nov 20, 2007 after 110 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- 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). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 20 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) Summary page 1.
- (no number) Cardinal Health Chroma-Line Cervical and Lumbar Spine Curettes: named in the summary without a submission number
- (no number) Kyphon, Inc., Kyphx Latitude Curette: named in the summary without a submission number

## Most influential descendants
- K100479: Parallax Contour Vertebral Augmentation Device (2010), 1 descendant of its own
- K130402: Spider System Kolibri Cement Needle (2013), 0 descendants of its own
- K110183: Arthrocare Parallax Contour Vertebral Augmentation Device (2011), 0 descendants of its own

## Indications for use
The AVAflex Vertebral Augmentation Needle is used during a vertebroplasty to fill a fractured vertebral body with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma. The AVAflex Vertebral Augmentation Needle is used during a kyphoplasty tc scrape and score bone in the spine to create a void within a fractured vertebral body and fill the void with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

Source page: https://510kreport.com/device/K072133
Methodology: https://510kreport.com/methodology