# K132639: CD Horizon Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Nov 25, 2013 after 94 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: 12 generations back to K040583 (2004). 81 ancestors in all.
243 later devices descend from it; 7 cite it directly.
1 of 325 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102807: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2010) Summary page 4.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 4.
- K052747: Modification to:CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 4.

## Most influential descendants
- K143375: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments (2015), 207 descendants of its own
- K153203: Navigation Instruments (2016), 112 descendants of its own
- K170679: CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems (2017), 86 descendants of its own
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (2016), 78 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own

## Indications for use
Trhe CD HORIZON® Spinal Systemn 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 stenlosis: curvatures (i.e., scoliosis, kyphosis arid/or lordosis); tumnor: pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as anl anterolateral thoracic/lumnbar system. the CD) HORIZON® Spinal System may also be used for thle samne indications as an adjunct to Fusion. With the exception ofdlegenerative disc disease, the CD HORIZON® L-EGACYTM 3.5mmn rods and tile CD HORIZON® Spinal System PEEK rods and associated components ma)' be used for the aforementioned indications in skeletally mnature patients as anl adjunct to fusion. Thle 3.51nn rods mnay be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients. the CD I IORIZON® Spinal Systemn implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the ClD HORIZON® Spinal Systemn is intended to treat pediatric patients diagnosed with the Following conditions: sponldylolisthiesis: firacture/dislocation: and/or traumna. These devices are to be used with autogral't and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach, The CD HORIZON SPIRETNI Plate is a posterior, single level. non-pedicle supplemental Fixation device intended for use in the non-cervical spine (TI-SI) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachmient to spinous processes for thle purpose of achieving supplemental Fixation in thle flollowing conditions: degenerative disc disease (as previously defined): spondvlolisthesis. trauma: and/or tumor. In order to achieve additional levels of' fixation, the CD) IIORIZON® Spinal System rods may be connected to thle VERTEX® Reconstruction System with the VERTEX®R rod connector. Refer to the VERTEX®9 Reconstruction Systemn Package Insert for a list of the VERTEX® indications of use.

Source page: https://510kreport.com/device/K132639
Methodology: https://510kreport.com/methodology