# K113174: CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Nov 21, 2011 after 25 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K040583 (2004). 72 ancestors in all.
596 later devices descend from it; 37 cite it directly.
1 of 669 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091974: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2009) Summary page 3.
- K102555: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2010) Summary page 3.
- K112473: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2011) Summary page 3.
- K112555: CD Horizon (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 3.
- K040962: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 4.
- K040072: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 4.
- K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 4.

## Most influential descendants
- K121680: CD Horizon Spinal System (2012), 357 descendants of its own
- K142847: CD HORIZON Spinal System (2014), 286 descendants of its own
- K130646: CD Horizon Spinal System (2013), 244 descendants of its own
- K132639: CD Horizon Spinal System (2013), 243 descendants of its own
- K122862: CD Horizon Spinal System (2012), 211 descendants of its own

## Recalls of this device
- Jul 9, 2018 · Class II · Z-2603-2018: This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier ta

## Indications for use
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same-indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implaats are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD HORIZON® SPIRE™ Plate is a poslerior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor. In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert-for a list of the VERTEX® indications of use.

Source page: https://510kreport.com/device/K113174
Methodology: https://510kreport.com/methodology