# K150460: KYPHON (R) HV-R (R) Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danck USA, Inc.
- Decided: Apr 28, 2015 after 64 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). 8 ancestors in all.
162 later devices descend from it; 2 cite it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093828: Kyph X HV-R Bone Cement, Medtronic, Inc. (2010) Summary page 4.
- K102397: Kyphon Xpede Bone Cement, Medtronic (2011) Summary page 5.

## Most influential descendants
- K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set (2016), 159 descendants of its own
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (2016), 106 descendants of its own
- K170347: CD HORIZON™ Fenestrated Screw Set (2017), 91 descendants of its own
- K171938: KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set (2017), 64 descendants of its own
- K160983: Kyphon HV-R Bone Cement (2016), 52 descendants of its own

## Indications for use
KYPHON® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.

Source page: https://510kreport.com/device/K150460
Methodology: https://510kreport.com/methodology