ostaPek® posterior lumbar interbody fusion cages.
The PLIF cages are designed for the posterior lumbar discectomy and fusion surgery. The evolution of the cage with the bullet design facilitates the insertion.
Clinically used in Europe since 1994. Cleared by the FDA under MAX code in 2018 510(k) K181963.
PLIF cages have been developed in the USA and are manufactured in Switzerland.
The ostaPek® Interbody Fusion Cages system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the sacro-lumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed via a posterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ostaPek Interbody Fusion Cages are to be used with supplemental fixation cleared by the FDA for use in the lumbar spine, i.e. GII System. Patients should have at least six weeks of non-operative treatment prior to surgery. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Examples of indications are discogenic lombalgy of 1 or 2 levels with bilateral canal stenosis, degenerative or isthmic spondylolisthesis.
Different combinations of width and length are available to cover the range of anatomical needs. The PLIF cages are designed in two lengths: standard = 25 mm and small = 20 mm, both types are available in three angles: 2˚, 5˚ and 7˚. The PLIF Bullet cages are designed in four lengths (standard = 25.8 mm, small = 20.8. mm, long = 30.8mm and X-long = 35.8mm) and are available in three angles: 2˚, 5˚ and 7˚.
For complete details on the use of the PLIF system refer to the valid Information for Use.