U&I Corporation VELOFIX SA Cervical Cage

Vendor/Manufacturer: U & I Corporation

Product/Product Line: Velofix SA Cervical Cage

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: OVE

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Integrated Fixation, Cervical

SUBSTANTIALLY EQUIVALENT to the following products:

1. Stryker AVS® Anchor-C Cervical Cage System

2. Dio Medical GALAXY (ACIF, PLIF, TLIF and ALIF) Peek cage

3. Zimmer BAK/C Anterior Cervical Interbody Fusion System

4. Synthes ZERO-P

5. Orthofix Cervical Stand Alone System

Device Description:

The Velofix SA Cervical Cage consists of cages, screws, locking plate and set screw.

The cages are available in various heights, width and have only 7˚ lordotic angle with an open architecture to accept packing of autograft or autogenous bone graft, while the medical grade titanium alloy screws have various diameters and length for fixing the cages. The locking plate, made of radiolucent PEEK and titanium alloy, is to prevent screw loosening. The medical grade titanium alloy set screw is intended for fixation of the locking plate. The Velofix SA Cervical Cage has two types:

1) The spacer which is made of radiolucent PEEK spacer (polymer polyether-ether-ketone, ASTM F2026) with the tantalum markers (ASTM F560).

2) The spacer which is a combination of radiolucent PEEK spacer with the x-ray markers and medical grade titanium alloy plate (Ti6Al4V ELI, ASTM F136).

The Velofix SA Cervical Cage is implanted as a single device via an anterior approach by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

Indications for Use:

The Velofix SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix SA Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Velofix SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.