# K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Incorporated
- Decided: Jan 6, 2016 after 117 days
- Product code: PML (Bone Cement, Posterior Screw Augmentation)
- 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: 12 generations back to K040583 (2004). 82 ancestors in all.
159 later devices descend from it; 13 cite it directly.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150460: KYPHON (R) HV-R (R) Bone Cement, Medtronic Sofamor Danck USA, Inc. (2015) Summary page 5.
- K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 5.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 5.

## Most influential descendants
- 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
- K191148: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (2019), 50 descendants of its own
- K170543: VIPER PRIME™ Screws with Fenestrations (2017), 48 descendants of its own

## Indications for use
When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised. When used in conjunction with KYPHON HV-R® Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K152604
Methodology: https://510kreport.com/methodology