# K060615: CD Horizon Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Oct 25, 2006 after 232 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 34 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040583 (2004). 13 ancestors in all.
822 later devices descend from it; 2 cite it directly.
1 of 836 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 3.
- K043565: Modification to Dynesys Spinal System, Zimmer Spine, Inc. (2005) Summary page 3.

## Cited in the summary but kept off the family tree
- K920291: Moni-Trol-L and Moni-Trol-XL, Medical Analysis Systems, Inc. (1992). Our reading of the summary gave K920291, FDA’s number for Moni-Trol-L and Moni-Trol-XL (Medical Analysis Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ATLAS Cable System”. Kept off the family tree. Summary page 3.

## Most influential descendants
- K063670: Modifications to CD Horizon Spinal System (2007), 821 descendants of its own
- K082236: CD Horizon Spinal System (2008), 779 descendants of its own
- K091442: CD Horizon Spinal System (2009), 776 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

## Recalls of this device
- Nov 12, 2007 · Not classified · Z-1434-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1431-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1421-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1439-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1414-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1415-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1424-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1419-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1438-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1430-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1433-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1417-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1408-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1412-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1422-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1436-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1423-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1410-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1418-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1435-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1411-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1426-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1416-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1420-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1413-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1428-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1437-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1440-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1409-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1441-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1429-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1425-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1432-2008: Breaks: Shear failure of the cable component of the system.
- Nov 12, 2007 · Not classified · Z-1427-2008: Breaks: Shear failure of the cable component of the system.

## 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) 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 a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). 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. 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 impairment, (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-S1) 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) kyphosis, 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) are having the device attached to the lumbar or sacral spine, and/or (3) are having the device removed after the development of a solid fusion mass. When used as a pedicle screw fixation system in skeletally mature patients, the CD HORIZON® AGILE™ Dynamic Stabilization Device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the degenerative spondylolisthesis with objective evidence of neurologic impairment and/or failed previous fusion in the thoracic, lumbar and/or sacral spine. Additionally, when used as a pedicle screw fixation system, the CD HORIZON® AGILE™ Dynamic Stabilization Device is indicated for use in patients who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and/or 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 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/K060615
Methodology: https://510kreport.com/methodology