External Fixation System TenXor - Stryker

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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

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