Vendor/Manufacturer: DePuy Synthes
Product/Product Line: EXPEDIUM® Spine System
Vendor/Manufacturer Catalog #: 1797-12-645
Global Unique Device (GUD) Primary Device Identifier Number: 10705034067735
Global Unique Device (GUD) Device Description:
SI Polyaxial Screw 5.5 x 6 x 45mm
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: 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 EXPEDIUM® Spine System is an innovative spine solution with technological advancements that differentiate it from other available systems.
The EXPEDIUM Spine System is a hook, screw and rod system. The system offers a comprehensive solution for rigid posterior fixation of the thoracolumbar regions of the spine. This unique system combines simplicity and versatility allowing the surgeon to design the construct based on intra-operative developments and individual patient anatomy – not the constraints of the system.
Benefits:
Monoaxial, polyaxial, uniplanar and reduction screws: Implants accommodate anatomy and surgeon preference
TOP NOTCHâ„¢ interface: Secure, in-line instrument attachment increases line of sight
Dual locking screw design: Offering the benefits, and flexibility of a polyaxial screw with the correction control of a monoaxial screw
Tapered screw tip and double lead thread form: Self-centers screw trajectory and reduces insertion time
Multiple rod reduction instruments: Provide control and power in rod reduction with surgeon preference in mind
Intended Use:The EXPEDIUM® Spine System is indicated for the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine as an adjunct to fusion in skeletally mature patients. These conditions include degenerative disc disease (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 failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.