Altus Spine Suzuka Cervical Inter-body Fusion (IBF) System

Vendor/Manufacturer: Altus Partners

Product/Product Line: Altus Spine Suzuka Cervical Inter-body Fusion (IBF) System

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: ODP

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Bone Graft, Cervical

SUBSTANTIALLY EQUIVALENT to the following products:

1. Alphatec Spine Novel Cervical Spinal Spacer System

2. Vertebron Interbody Fusion System

3. Altus Spine Titanium Interbody Fusion System

Device Description:

The Suzuka Cervical IBF System is designed to be implanted in the cervical spine to aid in the stability and support of vertebral bodies during fusion.

The Suzuka Cervical IBF System is a comprehensive cervical IBF system that includes both PEEK and Titani- um implants in three different footprints with common supporting instrumentation. Introducing Altus Spine’s MicroLOC™ technology, the Suzuka Titanium IBF implants incorporate the latest combination of macro- and micro-endplate surface texture design. MicroLOC™ surface technology results in a proprietary, porous grip surface intended to provide an optimal environment for initial bone growth while minimizing the potential for implant migration.

Indications for Use:

The Altus Spine Cervical Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from C3-C7. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Altus Spine Cervical Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Cervical Plate System.