# K170347: CD HORIZON™ Fenestrated Screw Set

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA
- Decided: Apr 4, 2017 after 60 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K040583 (2004). 83 ancestors in all.
91 later devices descend from it; 9 cite it directly.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 4.
- K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set, Medtronic Sofamor Danek USA, Incorporated (2016) Summary page 4.

## Most influential descendants
- K191148: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (2019), 50 descendants of its own
- K193011: CD Horizon™ Fenestrated Screw Set (2020), 41 descendants of its own
- K173487: CarboClear® Pedicle Screw System (2018), 41 descendants of its own
- K182377: CarboClear® Pedicle Screw System (2018), 39 descendants of its own
- K201362: CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement (2020), 38 descendants of its own

## Indications for use
When used without cement, the CD HORIZON Fenestrated Screws (with or without SEXTANT® or LONGITUDE® instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion. When used in conjunction with KYPHON HV-RT™ Fenestrated Screw Bone 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-RT™ 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/K170347
Methodology: https://510kreport.com/methodology