# K071927: Modification to Vertebroplastic Radiopaque Bone Cement

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, A Johnson & Johnson Company
- Decided: Nov 21, 2007 after 132 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: 4 generations back to K002652 (2001). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043406: Vertebroplastic Radiopaque Bone Cement, Depuy Spine, Inc. (2005) Summary page 1.
- K033382: Smartset GMV Endurance Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2004) Summary page 1.

## Most influential descendants
- K201831: CONFIDENCE Spinal Cement System (2020), 0 descendants of its own
- K112907: Confidence High Viscosity Spinal Cement, 16G / 20G (2011), 0 descendants of its own

## Indications for use
The VertebroplasticTM Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, mycloma).

Source page: https://510kreport.com/device/K071927
Methodology: https://510kreport.com/methodology