# K050809: CD Horizon Spinal System - Pathway: 510(k) (Traditional) - Applicant: Medtronic Sofamor Danek USA, Inc. - Decided: Jun 14, 2005 after 75 days - Product code: KWP (Appliance, Fixation, Spinal Interlaminal) - Device class: 2 - Regulation: 21 CFR 888.3050 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K040583 (2004). 28 ancestors in all. 870 later devices descend from it; 10 cite it directly. 1 of 899 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K043488: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 3. - K041862: CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 3. - K042962: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 3. - K000094: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2000) Summary page 3. - K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 3. - K032033: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 3. - K043151: Modification to: CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 3. - K021791: Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) - K031511: Dynesys Spinal System, Centerpulse Spine-Tech, Inc. (2004) ## Most influential descendants - K063670: Modifications to CD Horizon Spinal System (2007), 821 descendants of its own - K052187: Modification to: CD Horizon Spinal System (2005), 780 descendants of its own - K082236: CD Horizon Spinal System (2008), 779 descendants of its own - K053101: CD Horizon Spinal System (2006), 778 descendants of its own - K091442: CD Horizon Spinal System (2009), 776 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: ( I 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) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (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 (TI - S I). 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 confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. Tile CD HORIZON® LEGACY 3.5Srm 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 impairment, (2) firacture, (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 3.5umm 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. When used as a pedicle screw system in skeletally mature patients, the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphcosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: (1) are receiving fusion with autogenous graft only, (2) who are having the device attached to the lumbar or sacral spine, and/or (3) 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 VERTEXTM Reconstruction System with the VERTEXTM rod connector. Refer to the VERTEXTM Reconstruction System Package Insert for a list of the VERTEXTM indications of use. Source page: https://510kreport.com/device/K050809 Methodology: https://510kreport.com/methodology