Vendor/Manufacturer: Signature Orthopaedics
Product/Product Line: BRISBANE ALIF Device
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3080
FDA Regulation Description Classification Name:
Intervertebral Body Fusion Device
FDA Classification Product Code: OVD
FDA Classification Product Code Device Name:
Intervertebral Fusion Device With Integrated Fixation, Lumbar
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The Signature Orthopaedics Brisbane ALIF cages are manufactured from PEEK-OPTIMA LT1 per ASTM-F2026. The Screws for Brisbane ALIF cages are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136. The Brisbane ALIF cages consist of a wedge-shaped geometry and intended for implantation by an anterior approach. The center of the cages are hollow to allow loading of bone graft. The cages are wedge shaped to restore lordosis of the fused vertebral bodies. The superior and inferior surfaces have serrated teeth to resist expulsion. The cages have three holes each on their anterior faces to facilitate the use of titanium bone screws. The use of the bone screws make the subject cages stand-alone cages. The superior and inferior surfaces of Brisbane ALIF cage is Titanium Plasma Spray (TPS) coated per ASTM-F1580.
Indications for Use:
The Signature Orthopaedics Brisbane ALIF systems are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The Brisbane ALIF systems may be used as stand-alone devices or in conjunction with supplemental fixation. When used as a stand-alone device the subject devices must be used with all three screws.
Comments