# K050981: CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: May 17, 2005 after 28 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 3 generations back to K981676 (1999). 10 ancestors in all.
786 later devices descend from it; 4 cite it directly.
1 of 797 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041862: CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K050079: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2005) Summary page 2.
- K040583: Modification to: CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K043488: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.

## Most influential descendants
- K053101: CD Horizon Spinal System (2006), 778 descendants of its own
- K091442: CD Horizon Spinal System (2009), 776 descendants of its own
- K090390: CD Horizon Spinal System (2009), 663 descendants of its own
- K091974: Modification to CD Horizon Spinal System (2009), 656 descendants of its own
- K102555: CD Horizon Spinal System (2010), 598 descendants of its own

## Indications for use
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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. When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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; pseudoarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylblisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosfA (7) tumor resection, and/or (8) failed previous fusion. The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S 1S).It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confuimed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic inpairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-Sl) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEXW Reconstruction System with the VERTEX"' rod connector. Refer to the VERTEX m Reconstruction System Package Insert for a list of the VERTEXTM indications of use.

Source page: https://510kreport.com/device/K050981
Methodology: https://510kreport.com/methodology