FORZA XP Expandable Spacer System

FORZA®XP可扩展的垫片系统提供钛合金可扩展的腰部叶片间叶片，用于后腰椎间融合（PLIF）和经膜片腰椎室内融合（TLIF）程序。插入椎间盘空间后，可以扩展散布以适应患者的解剖结构。与许多竞争性扩展的物品不同，这些扩展物可以在其扩展设计的范围内进行交流空间，而Forza XP具有较大的移植窗口，并为用户提供了在保持其扩展能力的同时将移植窗打包的能力。

Product Highlights

  • Minimized insertion height helps to reduce nerve root retraction and minimize impaction force
  • Controlled continuous expansion† – not incremental like some competitors
  • In situ distraction allows disc height restoration and an optimized fit
  • Automatic locking – height stability without an extra locking step
  • Anatomic profile – optimal fit within vertebral endplates*
  • 插入器留在适当的位置，用于插入，扩展和移植物材料后包装 - 通过仪器较少通过神经根的通行证
  • 膨胀后骨移植的放置 - 能够用原位填充移植物窗户空间

*Note: 6.5mm implants do not have anatomic endplates

†Controlled expansion up to 3mm

Indications

The FORZA XP Expandable 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 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZA XP Expandable Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. Firebird® Spinal Fixation System).

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA XP Expandable Spacer System.

Contraindications

与其他骨科植入物一样，Forza XP可扩展的垫片系统禁忌用于以下患者：

  • Active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection.
  • Rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis which may prevent adequate fixation.
  • 可能对骨骼和植入物（例如严重的肥胖症，妊娠或退化性疾病）施加过度压力的疾病。在这种情况下使用该系统的决定必须由医生考虑到风险与患者的好处。
  • 先前在要处理的水平上进行融合。
  • 任何情况未在使用条件下列出的任何情况。

Instructions For Use

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