External Fixation System TenXor - Stryker

TenXor
External Fixation System
Hybrid System for Lower Extremity

Contents
Page
1. Introduction 3
2. Features & Benefits 4
Ease of Use 4
Simple Adaptation 5
Modularity 5
Free Wire Placement 6
Simple Instrumentation 6
3. Relative Indications & Contraindications 7
Relative Indications 7
Relative Contraindications 7
4. Related Stryker Products 8
Hoffmann II Compact 8
Asnis III Cannulated Screws 8
AxSOS Locking Plate System 8
Ordering Information – Implants 9
Ordering Information – Instruments 10
Additional Information 11
2

Introduction
In severe trauma cases, it
is necessary to have a good
partnership, whether it is a
colleague in the surgical theatre
or an effective and trustworthy
system that allows you to bring the
focus to where it belongs - on the
patient.
The TenXor system, a hybrid
External Fixator for peri- and
intra-articular fractures of the
lower extremity is especially
designed to fulfill the needs of
today’s surgeons. The advanced
technology helps to provide
simplicity and efficiency of
application.
The right focus - possible
with the TenXor system.
Thanks to technical features
like the patented* “Snap Fit”
mechanism, adaptation of height
from the Wire Post and an
unlimited range of motion on
the ring, the TenXor delivers the
features surgeons need during a
trauma procedure. Focus is on
the patient and their injuries. The
TenXor adapts to the treatment
requirements of the injury
without compromising the clinical
outcome.
During wire insertion,
concentration can be completely
on the fracture and the soft
tissues. The TenXor provides the
possibility to adapt the frame even
for non parallel wires.
Do you have a need to change
the frame elasticity during the
treatment?
The compatibility with the
modular Hoffmann II system and
Monotube TRIAX system allows
adaptation of frame elasticity to
the healing process.
The TenXor system is a part of
the Hoffmann II family. The
combination of simplicity and
versatility solves your daily
challenges in the surgical theatre
more effectively.
* US Patents 6,080,153; 5,752,954 and
EP 0 700 664
3

Features & Benefits
Ease of Use
The “Snap Fit” mechanism is designed
to provide a quick, easy and secure
frame construction. With a small
number of components and a few
bolts and nuts to tighten, working on
the frame is much facilitated. The
minimal instrumentation needed
is compatible with the Hoffmann II
instrumentation.
High technology carbon material
of the rings provides a better
radiolucency and the etched end of
the olive wires allow a simple removal
without additional x-ray control.
4

Simple Adaptation
The 5/8 open carbon rings facilitate
the selection of the ring size by
sliding it over the extremity directly
during surgery. Due to the “Snap
Fit” mechanism, absolutely no
pre-assembling is necessary. All
components have direct positioning
access to the ring construction.
Additionally the “Snap Fit”
mechanism provides the possibility
to add or remove components to
create the optimal stability during the
treatment with a “Click”.
Modularity
The compatibility with the
Monotube TRIAX and the
Hoffmann II systems provide the
adaptation of elasticity during
treatment. It also adds the option of
independent pin placement and joint
bridging if desired. The “Snap Fit”
mechanism with a “Click” delivers the
solution of a dynamic system.
For more information we refer to the
Hoffmann II brochure (ref.-no. 5075-
1-000) and the Monotube TRIAX
brochure (ref.-no. 5075-2-500).
5

Features & Benefits
Free Wire
Placement
The TenXor system has been designed
for effective wire placement adaptable
to fractures and anatomical needs.
The wires can be placed prior and
independently to the frame assembling.
The Ring Clamp provides unlimited
positioning on the ring and the
attachable Wire Post has a height
adjustability up to 2.5 cm with
angulations of +/-20°.
Simple
Instrumentation
Only a few instruments and the
compatibility with the
Hoffmann II instruments facilitate the
work significantly.
The self-explanatory wire tensioner
renders an optimal tensioning of the
wires.
TenXor
Your system for effective solutions.
6

Relative Indications & Contraindications
Since external fixation devices are
often used in emergency situations to
treat patients with acute injuries, there
are no absolute contraindications for
use. The surgeon’s education, training
and professional judgement must
be relied upon to choose the most
appropriate device and treatment for
each individual patient.
If uncertainly exists with regard to the
anatomic location of the neurovascular
structures due to post-traumatic
destruction, the device should be used
with extreme caution. Under these
circumstances, the wires and pins
should be inserted under direct vision.
Relative
Indications
• Severe multi fragmentary tibia
plateau fractures, e.g. Schatzker
type (4), 5, 6
• Severe multi fragmentary pilon
fractures, e.g. Rüedi & Allgöwer type
2, 3
• Severe distal femur fractures, e.g. AO
33B, 33C
• Secondary fixation after failure or
infection of primary fixation
• Less complex fracture pattern with
severe soft tissue damage, e.g.
Tscherne type C2, C3,
Gustillo Andersen type (2), 3
Relative
Indications
• Patients with compromised immune
system
• Non compliant patients who would
not be able to ensure proper wire and
pin care
• Pre-existing internal fixation
that prohibits proper wire or pin
placement
• Bone pathology precluding pin
fixation
7

Related Stryker Products
Hoffmann II Compact
The Hoffmann II Compact External
Fixation system gives the surgeon the
ability to treat a variety of fractures in
the wrist, forearm and foot. This low
profile, modular system is compatible
with the TenXor system and adapts
easily to the patients anatomy and soft
tissues.
For more information, contact your
local Stryker Representative and
ask for the Hoffmann II Compact
brochure (ref.no. 5075-1-500).
Asnis III Cannulated Screws
This new generation of Cannulated
Screws has been designed to optimize
surgical outcomes while simplifying
procedures.
For more information, contact your
local Stryker Representative and ask for
the ASNIS III brochure
(ref.no. 982187).
AxSOS Locking Plate System
The AxSOS Locking Plate System is
designed to treat periarticular or intraarticular
fractures of the Proximal
Humerus, Distal Femur, Proximal
Tibia and the Distal Tibia. The system
design is based on clinical input from
an international panel of experienced
surgeons, data from literature, and
both practical and biomechanical
testing. The anatomical shape, the
fixed screw trajectory, and high surface
quality take into account the current
demands of clinical physicians for
appropriate fixation, high fatigue
strength and minimal soft tissue
damage.
Proximal Lateral
Tibial Plate
For more information contact your
local Stryker Representative and ask for
the relevant Operative Technique.
Distal Anterolateral
Tibial Plate
8

Ordering Information – Implants
REF
Description
Ring Components
4936-0-015 Open Ring, 150mm
4936-0-018 Open Ring, 180mm
4936-0-021 Open Ring, 210mm
4936-2-010 Ring Clamp
4936-2-040 Wire Post, 1.5, 2.0mm
4936-2-050 Wire Post, short, 1.5, 2.0mm
4936-2-030 Pin Post, 4,5,6mm
4936-2-920 Ring to Monotube Triax Tube Clamp, blue, 20mm
4936-2-925 Ring to Monotube Triax Tube Clamp, red, 25mm
Wires
5101-1-450 Wire 450mm, 1.5mm
5101-2-450 Wire 450mm, 2.0mm
4936-1-320 Wire etched, with olive, 1.5mm
4936-1-340 Wire etched, with olive, 2.0mm
9

Ordering Information – Instruments
REF
Description
4936-9-010 TenXor Wire Tensioner
4936-9-020 Wire Cutting and Bending Plier , max. 2.0mm
4936-9-035 Quick Capture Spanner Wrench, 13mm
4936-9-040 Split Wire Sleeve
4936-9-050 Stabilization Wrench
4936-9-060 T-Wrench, 7mm
4936-9-070 Cardan Wrench, 7mm
4920-9-036 Spanner Wrench, 7mm
4936-9-900 Storage Case - TenXor
10

Additional Information
HydroSet
Injectable HA
Indications
HydroSet is a self-setting calcium
phosphate cement indicated to fill
bony voids or gaps of the skeletal
system (i.e. extremities, craniofacial,
spine, and pelvis). These defects may
be surgically created or osseous defects
created from traumatic injury to the
bone. HydroSet is indicated only
for bony voids or gaps that are not
intrinsic to the stability of the bony
structure.
HydroSet cured in situ provides an
open void/gap filler than can augment
provisional hardware (e.g K-Wires,
Plates, Screws) to help support
bone fragments during the surgical
procedure. The cured cement acts
only as a temporary support media
and is not intended to provide
structural support during the healing
process.
Tibial Plateau Void Filling
Scanning Electron Microscope Image
of Hydroset material crystalline
microstructure at 15000x
magnification
HydroSet is an injectable,
sculptable and fast-setting bone
substitute. HydroSet is a calcium
phosphate cement that converts to
hydroxyapatite, the principle mineral
component of bone. The crystalline
structure and porosity of HydroSet
makes it an effective osteoconductive
and osteointegrative material, with
excellent biocompatibility and
mechanical properties 1 . HydroSet
was specifically formulated to set in
a wet field environment and exhibits
outstanding wet-field characteristics 2 .
The chemical reaction that occurs as
HydroSet hardens does not release heat
that could be potentially damaging
to the surrounding tissue. Once set,
HydroSet can be drilled and tapped
to augment provisional hardware
placement during the surgical
procedure. After implantation, the
HydroSet is remodeled over time at a
rate that is dependent on the size of the
defect and the average age and general
health of the patient.
Advantages
Injectable or Manual
Implantation
HydroSet can be easily implanted via
simple injection or manual application
techniques for a variety of indications.
Fast Setting
HydroSet has been specifically designed
to set quickly once implanted under
normal physiological conditions,
potentially minimizing procedure
time.
Isothermic
HydroSet does not release any heat as
it sets, preventing potential thermal
injury.
Excellent Wet-Field
Characteristics
HydroSet is chemically formulated
to set in a wet field environment
eliminating the need to meticulously
dry the operative site prior to
implantation. 2
Osteoconductive
The composition of hydroxyapitite
closely matches that of bone mineral
thus imparting osteoconductive
properties. 3
Augmentation of Provisional
Hardware during surgical
procedure
HydroSet can be drilled and tapped
to accommodate the placement of
provisional hardware.
References
1. Chow, L, Takagi, L. A Natural Bone Cement –
A Laboratory Novelty Led to the Development of
Revolutionary New Biomaterials. J. Res. Natl. Stand.
Technolo. 106, 1029-1033 (2001).
2. 1808.E703. Wet field set penetration
(Data on file at Stryker)
3. Dickson, K.F., et al. The Use of BoneSource
Hydroxyapatite Cement for Traumatic Metaphyseal
Bone Void Filling. J Trauma 2002; 53:1103-1108.
Note:
Screw fixation must be provided
by bone
11
Ordering Information
Ref Description
397003 3cc HydroSet
397005 5cc HydroSet
397010 10cc HydroSet
397015 15cc HydroSet
Note:
For more detailed information
refer to Litterature No. 90-07900.

Stryker Trauma AG
Bohnackerweg 1
CH-2545 Selzach
Switzerland
www.osteosynthesis.styker.com
This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her
own professional clinical judgment when deciding whether to use a particular product when treating a particular
patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any
particular product before using it in surgery. The information presented in this brochure is intended to
demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions including
the instructions for Cleaning and Sterilization (if applicable) before using any Stryker products. Products may not
be available in all markets. Product availability is subject to the regulatory or medical practices that govern
individual markets. Please contact your Stryker representative if you have questions about the availability of
Stryker products in your area.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following
trademarks or service marks: Stryker, Asnis, AxSOS, Hoffmann, HydroSet, TenXor.
All other trademarks are trademarks of their respective owners or holders.
The products listed above are CE marked.
Literature Number: 5075-3-000
LOT F2209
Copyright © 2009 Stryker