Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: CD Horizon Solera Voyager Screw
Vendor/Manufacturer Catalog #: 6440530
Global Unique Device (GUD) Primary Device Identifier Number:
NA
Global Unique Device (GUD) Device Description:
NA
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
NA
Category 1: Spine
Category 2: Lumbar Pedicle Screw Systems
Category 3: Set Screw
Category 4: Two Level
Quantity of "Each"es needed in each System/Set: 6
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3070
FDA Regulation Description Classification Name:
Pedicle Screw Spinal System
FDA Classification Product Code: NKB
FDA Classification Product Code Device Name:
Thoracolumbosacral Pedicle Screw System
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Additions to the existing CD HORIZON® SOLERA® Ø5.5/6.0 Spinal System:
Ø5.5/6.0 Awl Tap Screws (ATS)
Ø5.5 Capped Rods
Ø5.5 Percutaneous Rods
Additions to the existing CD HORIZON® SOLERA® VOYAGER™:
Ø4.75 Spinal System
Ø4.75 Awl Tap Screws (ATS)
Creating the new CD HORIZON® SOLERA® VOYAGER™:
Ø5.5/6.0 Spinal System
Cannulated Multi-Axial Screws (MAS)
Awl Tap Screws (ATS)
Capped Rods
Percutaneous Rods
Tab Extenders
Extender Cap
Taps and Driver compatible with IPC® POWEREASE® System
Navigated Driver compatible with STEALTHSTATION® and IPC® POWEREASE® Systems
System specific cases and trays
Indications for Use:
The CD HORIZON® Spinal System 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 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, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK 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, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ 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: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor. 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.