SynCage – Open. Vertebral body
devices intended for use in the
thoracolumbar spine.
Made of
biocompatible
titanium alloy
Textured surface
for enhanced bone
adhesion
Axial canals for
graft material
Instruments and implants
approved by the AO Foundation
SynCage – Open
Features
– Biocompatible titanium alloy, Ti-6Al-7Nb
– Convex superior and inferior surfaces enhance anatomical
interface with vertebral endplates
– Lordotic shape (8°) restores natural sagittal alignment
– Design allows simultaneous distraction and implant insertion
– Axial canal and lateral windows for autograft or other graft
material allow fusion to occur through the implant
– Teeth on superior and inferior surfaces provide secure
engagement with adjacent vertebral bodies
– Two styles accommodate varying surgical approaches:
anterior and anterolateral
– Surface texture for enhanced bone adhesion
– Heights from 9 mm through 21 mm, in 2 mm increments
– Anatomical footprint of 24 mm depth x 30 mm width
24 mm depth
30 mm width
Implant for anterior insertion
8º
H*
Lordotic design
45º
Implant for anterolateral insertion
* Height is measured from top of teeth as shown
Synthes Spine SynCage – Open
Indications
The SynCage implant is a vertebral body replacement device
intended for use in the thoracolumbar spine (T1–L5) to replace
a collapsed, damaged, or unstable vertebral body due to tumor
or trauma (i.e., fracture). The SynCage implant is intended to
be used with Synthes supplemental internal fixation systems,
e.g., ATLP, VentroFix, USS (including Click’X) and Small Stature
USS. The interior of the spacer component of the SynCage
implant can be packed with bone. The SynCage implants are
designed to provide anterior spinal column support even in
the absence of fusion for a prolonged period.
Please refer to package insert for complete system description,
indications, contraindications and warnings.
Synthes Spine
1
SynCage – Open Implant Holders
SynCage Implant Holders allow two different surgical
approaches: anterior and anterolateral.
Anterior approach
to be used with SynCage Implant Holder, straight (397.087)
Shown with Curved Distractor
(396.941)
Anterolateral approach
to be used with SynCage Implant Holder, offset (397.088)
Important: SynCage – Open, anterolateral, 9 mm, has
anterior implant holder slot only
Shown with Curved Distractor
(396.941)
2
Synthes Spine SynCage – Open
Material
SynCage implants are manufactured from a titanium alloy,
Ti-6Al-7Nb. The surface structure of the implant is textured
to allow better bone adhesion. Shown at right is an electron
microscope image of the implant surface (600 μm).
Compressive Strength
25,000
20,000
Compressive Load (N)
Testing
Testing was conducted to ensure that SynCage–Open can
withstand clinically relevant loads in the lumbar spine. The
ultimate compressive load that a vertebral body can withstand
is 8,000 N.1 Test results show that SynCage–Open can withstand compressive loads of over 25,000 N (Figure 1).2 Additional testing was conducted to ensure that SynCage–Open
could resist expulsion at clinically relevant loads. The maximum
shear force that a human disc can withstand is approximately
150 N.3 Test results show that SynCage–Open can withstand
expulsion loads of 1,402 N (Figure 2).4
15,000
10,000
5,000
0
SynCage – Open
Vertebral Body
Figure 1
Pushout Strength
1500
Load (N)
1200
900
600
1. O. Perry. “Fracture of the vertebral endplate in the lumbar spine.” Acta. Orthop.
Scand. 1957; 25 (suppl.)
2. Testing performed at the Mechanical Testing Laboratory, Synthes Spine,
West Chester, PA.
3. A.A. White and M.M. Panjabi. Clinical Biomechanics of the Spine. Philadelphia:
Lippincott, William and Wilkins. 1990. 7, 9.
4. Testing performed at Synthes Spine.
Mechanical Test Results are not necessarily indicative of clinical performance.
300
0
SynCage–Open
Human Disc
Figure 2
Synthes Spine
3
SynCage–Open Implants
Implants
495.263
495.264
495.265
495.266
495.267
495.268
495.269
SynCage–Open, anterior
Height (mm)
9
11
13
15
17
19
21
495.270
495.271
495.272
495.273
495.274
495.275
495.276
SynCage–Open, anterolateral
Height (mm)
9
11
13
15
17
19
21
Also available
397.087
397.088
SynCage Implant Holders
Straight
Offset
Note: For additional information, please refer to package insert.
For detailed cleaning and sterilization instructions, please refer to
http://us.synthes.com/Medical+Community/Cleaning+and+Sterilization.htm
or to the below listed inserts, which will be included in the shipping container:
—Processing Synthes Reusable Medical Devices—Instruments, Instrument Trays
and Graphic Cases—DJ1305
—Processing Non-sterile Synthes Implants—DJ1304
4
Synthes Spine SynCage – Open
Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380
Telephone: (610) 719-5000
To order: (800) 523-0322
Fax: (610) 251-9056
© 2003 Synthes, Inc. or its affiliates. All rights reserved.
Synthes (Canada) Ltd.
2566 Meadowpine Boulevard
Mississauga, Ontario L5N 6P9
Telephone: (905) 567-0440
To order: (800) 668-1119
Fax: (905) 567-3185
Click'X, SynCage, VentroFix and Synthes are trademarks of Synthes, Inc. or its affiliates.
www.synthes.com
Printed in U.S.A.
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