The FORZA PTC Spacer System has been designed to help optimize Transforaminal Lumbar Interbody Fusion(TLIF), Posterior Lumbar Interbody Fusion (PLIF) and Oblique Lumbar Interbody Fusion procedures with surgeon designed implants and instruments. FORZA PTC Spacers offer a unique technology that combines PEEK and titanium into a porous interbody solution for the lumbar spine. This PEEK/Titanium hybrid is designed with a 3D porous endplate that allows the patient bone to grow into its surface creating a bond between the implant and the patient bone.
The FORZA PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).
The FORZA PTC Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.
The FORZA PTC Spacer System, as with other orthopedic implants, is contraindicated for use in patients:
FORZA PTC Spacer System IFU