STALIF MIDLINE

K101301MAX9/24/2010

Applicant

CENTINEL SPINE

Intended Use

The STALIF MIDLINET™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.

Indications for Use

The STALIF MIDLINET™ is 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 non-operative 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 STALIF MIDLINET™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF MIDLINET™ system must be used with bone grafting material (autograft only).

Predicate Devices