Vendor/Manufacturer: Orthofix
Product/Product Line: FIREBIRD® Spine System
Vendor/Manufacturer Catalog #: 52-6040
Global Unique Device (GUD) Primary Device Identifier Number: 18257200116393
Global Unique Device (GUD) Device Description:
40mm Rod, Pre-Lordosed, anodized
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Bone-screw internal spinal fixation system, non-sterile
Category 1: Spine
Category 2: Lumbar Pedicle Screw Systems
Category 3: Rod
Category 4: One Level
Quantity of "Each"es needed in each System/Set: 2
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 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System are temporary, multiple component systems comprised of a variety of non-sterile and sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine.
The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System consist of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.
Indications for Use:
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:
1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. spondylolisthesis
3. trauma (i.e., fracture or dislocation),
4. spinal stenosis
5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. tumor
7. pseudoarthrosis
8. failed previous fusion
When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level. The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors. When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended to be used with autograft or allograft.
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