The Peek Cage System Implants - Chm Charspine System Bedienungsanleitung

THE PEEK CAGE SYSTEM IMPLANTS

1 PURPOSE AND INDICATIONS
1. The PLIF PEEK, TLIF PEEK, ALIF PEEK and cervical intervertebral cages are
made of biocompatible PEEK (polyetheretherketone). These implants are
offered in various heights and lordotic angles to adapt best to a variety
of patient anatomies. The implants have serrated superior and inferior
surfaces for fixation and hollow geometry that allows them to be packed
with autogenous bone grafts.
1) The cervical intervertebral cages are indicated for vertebral arthrodesis
of cervical body procedures in patients with degenerative disc disease
(DDD). The implants should be used for adjacent vertebral bodies at lev-
els from C2 to T1. The cervical intervertebral cages are designed to be
used with autogenous bone graft and are intended for use with supple-
mental fixation systems cleared for use in the cervical spine (e.g. anterior
cervical plates).
2) The PLIF PEEK and TLIF PEEK intervertebral cages are indicated for pos-
terior and posterolateral (transforaminal) approach, respectively. They
are used in the treatment of degenerative disc disease (DDD), vertebral
instability, Grade 1 spondylolisthesis as well as in the cases of spine re-
vision surgery. The implants should be used at one or two contiguous
levels from L2 to S1. The implants are designed to be used with autog-
enous bone graft and are intended for use with supplemental fixation
systems, cleared for use in the lumbar spine (e.g. posterior pedicle screw
and rod systems).
a) The PLIF PEEK intervertebral cage has atraumatic, ogival anterior por-
tion. This device can be inserted between two lumbar or lumbosacral
vertebral bodies to give support and correction during lumbar inter-
body fusion surgeries. Radiopaque markers have been embedded
within the implant to allow for visualization in radiographic images.
CAUTION: The PLIF PEEK intervertebral cages are designed to be im-
planted bilaterally (in pairs).
b) The TLIF PEEK intervertebral cage has a curved, kidney-shaped geom-
etry to match the vertebral anatomy and an adjustable articulated
mechanism allowing the rotation of the implant in situ. Radiopaque
markers have been embedded within the implant to allow for visual-
ization in radiographic images.
3) The ALIF PEEK intervertebral cage is designed for use with an autograft,
for anterior vertebral arthrodesis at one level or two contiguous levels
of lumbar spine. The implants are indicated for the treatment of degen-
erative disc disease (DDD) and Grade 1 spondylolisthesis in lumbar spine
from L2 to S1.
a) The ALIF PEEK intervertebral cage is intended for use with supple-
mental fixation systems, cleared for use in the lumbar spine surgeries
(e.g. pedicle screw and rod systems).
b) The ALIF PEEK locking intervertebral cage is to be used as a stand-alone
implant (without any additional stabilization systems). It is equipped
with integrated titanium insert which together with four locking bone
screws provide secure locking mechanism to stable fixation of vertebral
bodies. Radiopaque markers have been embedded within the implant
to allow for visualization in radiographic images.
4) Degenerative intervertebral disc disease (DDD) is defined as radiculopa-
thy and/or myelopathy with herniated disc and/or osteophyte forma-
INSTRUCTIONS FOR USE
Important product information for
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