# K253335: CD Horizon™ Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Oct 24, 2025 after 24 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: 33 generations back to K841189 (1984). 837 ancestors in all.
No later device cites it as a predicate yet.
1 of 838 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243007: CD Horizon™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2024) Summary page 5.
- K223494: CD Horizon Spinal System, Medtronic (2023) Summary page 5.
- K221244: CD Horizon™ Spinal System, Medtronic (2022) Summary page 5.
- K211958: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 5.
- K210637: CD Horizon™ Spinal System, Medtronic (2021) Summary page 5.
- K203678: CD HORIZON™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 5.
- K173249: CD HORIZON™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 5.
- K102555: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2010) Summary page 5.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 5.

## Indications for use
The CD Horizon TM Spinal System with or without SextantT instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon TM Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD HorizonT" Legacy TM 3.5mm 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, CD HorizonT Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis,kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HorizonT Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD Horizon TM PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD HorizonTM SpireTr plate is a posterior, 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: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor. To achieve additional levels of fixation, CD HorizonTM Spinal System rods may be connected to the VertexT Reconstruction System with the VertexT rod connector. Refer to the VertexTM Reconstruction System package insert for a list of the VertexTMindications of use.

Source page: https://510kreport.com/device/K253335
Methodology: https://510kreport.com/methodology