# K043406: Vertebroplastic Radiopaque Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Jul 15, 2005 after 217 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: 3 generations back to K002652 (2001). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041584: Kyphx HV-R Bone Cement, Model C01A, Kyphon, Inc. (2004) Summary page 1.
- K032945: Simplex X, Stryker Corp. (2004) Summary page 1.
- K002652: Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii, Stryker Corp. (2001) Summary page 1.
- K873689: Cranioplastic, Acrylic Cranioplasty Material, Dentsply Intl. (1987) Summary page 1.

## Most influential descendants
- K071927: Modification to Vertebroplastic Radiopaque Bone Cement (2007), 2 descendants of its own
- 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
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 (hemangionra), or malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K043406
Methodology: https://510kreport.com/methodology