Indications
Synthes Spine
3
The Synthes USS (including the Click’X, USS VAS v
a
ri
ab
le
a
xis
components,
a
nd P
a
nge
a
), Click’X Mono
a
xi
a
l, P
a
nge
a
Mono
a
xi
a
l, Du
a
l-Opening
a
nd the Sm
a
ll St
a
ture USS (which
includes sm
a
ll st
a
ture
a
nd pedi
a
tric p
a
tients)
a
re noncervic
a
l
spin
a
l fix
a
tion devices intended for use
a
s posterior pedicle
screw fix
a
tion systems (T1–S2),
a
posterior hook fix
a
tion
system (T1–L5), or
a
s
a
n
a
nterol
a
ter
a
l fix
a
tion system (T8–L5).
Pedicle screw fix
a
tion is limited to skelet
a
lly m
a
ture p
a
tients
with the exception of the Sm
a
ll St
a
ture USS. These devices
a
re indic
a
ted for
a
ll of the following indic
a
tions reg
a
rdless of
the intended use: degener
a
tive disc dise
a
se (defined
a
s disco-
genic
ba
ck p
a
in with degener
a
tion of the disc confirmed
b
y
history
a
nd r
a
diogr
a
phic studies), spondylolisthesis, tr
a
um
a
(i.e., fr
a
cture or disloc
a
tion), deformities or curv
a
tures (i.e.,
scoliosis, kyphosis,
a
nd/or lordosis, Scheuerm
a
nn’s dise
a
se),
tumor, stenosis, pseudo
a
rthrosis,
a
nd f
a
iled previous fusion.
When tre
a
ting p
a
tients with degener
a
tive disc dise
a
se (DDD),
tr
a
nsverse
ba
rs
a
re not cle
a
red for use
a
s p
a
rt of the posterior
pedicle screw construct.
When used with the 3.5 mm/6.0 mm p
a
r
a
llel connectors,
the Synthes USS (including the Click'X, USS VAS v
a
ri
ab
le
a
xis
components,
a
nd P
a
nge
a
), Click'X Mono
a
xi
a
l, P
a
nge Mono-
a
xi
a
l,
a
nd Du
a
l-Opening USS c
a
n
b
e linked to the CerviFix
system. In
a
ddition, when used with 3.5 mm/5.0 mm p
a
r
a
llel
connectors, the Synthes Sm
a
ll St
a
ture USS, c
a
n
b
e linked to
the CerviFix system. When used with the 5.0 mm /6.0 mm
p
a
r
a
llel connectors, the Synthes Sm
a
ll St
a
ture USS c
a
n
b
e
linked to the Synthes USS (including the Click'X, USS VAS
v
a
ri
ab
le
a
xis components,
a
nd P
a
nge
a
), the Click'X Mono
a
x-
i
a
l, P
a
nge
a
Mono
a
xi
a
l,
a
nd Du
a
l-Opening USS systems.
In
a
ddition, Synthes USS (including the Click’X, USS VAS
v
a
ri
ab
le
a
xis components,
a
nd P
a
nge
a
), Click’X Mono
a
xi
a
l,
P
a
nge
a
Mono
a
xi
a
l
a
nd the Du
a
l-Opening USS c
a
n
b
e inter-
ch
a
nged with
a
ll USS 6.0 mm rods
a
nd tr
a
nsconnectors.
