Signature Orthopaedics ARLINGTON PLIF / TLIF Cage

Vendor/Manufacturer: Signature Orthopaedics

Product/Product Line: ARLINGTON PLIF / TLIF 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: MAX

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Bone Graft, Lumbar

SUBSTANTIALLY EQUIVALENT to the following products:

1. DePuy CONCORDE Curve

2. Spineart DYNAMIK Lumbar Interbody Device

3. DePuy Lumbar I/F

Device Description:

The Signature Orthopaedics Arlington PLIF/TLIF cages are manufactured from PEEK OPTIMA LT1 per ASTM-F2026. The Arlington PLIF/TLIF cage is intended for implantation by a posterior or transforminal approach.

The device consists of a rectangular cage geometry with a bulleted tip to ease insertion and serrated teeth on the inferior and superior surfaces to resist expulsion from the disc space. The center of the cage is hollow to allow loading of bone graft.

Indications for Use:

The Signature Orthopaedics Arlington PLIF/TLIF system is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of nonoperative treatment prior to surgery. The device is to be used with autogenous bone graft. The Arlington PLIF/TLIF is used to facilitate fusion in the lumbar spine and are placed using either a PLIF or TLIF approach. Arlington PLIF/TLIF system is intended for use with supplemental internal fixation products.