HydroSet Injectable HA HydroSet Injectable HA - Stryker

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HydroSet Injectable HA HydroSet Injectable HA - Stryker

HydroSet

Injectable HA

Storage Information

Product Specifications

Packaging Contains:

• Mixing bowl with powder

• Liquid filled syringe

• Cement delivery syringe barrel with

preattached funnel

• Syringe plunger

• 8ga cannula with adapter

• Spatula

• Blister tray with syringe stand feature

Shelf Life: 2 years

Sterilization:

Ethelyne oxide and Gamma irradiation

Trauma, Extremities & Deformities

Biologics

Surgical Products

Neuro & ENT

Trauma, Extremities & Deformities

Biologics

Surgical Products

Neuro & ENT

HydroSet

Injectable HA

The difference in

Bone Substitute Technology

• Fast Setting

• Excellent wet-field properties

• Osteoconductive

• Enhanced screw fixation in cancellous

bone at and after surgery

8ga,10ga and 12ga cannulas are available as single use,

sterile packaged to meet a variety of surgeons needs.

• 8ga cannula OD = 4.2mm

• 10ga cannula OD = 3.4mm

• 12ga cannula OD = 2.8mm

Stryker Leibinger GmbH & Co. KG

Bötzinger Straße 41

D-79111 Freiburg - Germany

www.osteosynthesis.stryker.com

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 before using any Stryker product. Surgeons

must always rely on their own clinical judgment when deciding which products and techniques

to use with their patients. 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 subsidiary owns the registered trademark: Stryker

Stryker Corporation or its subsidiary owns, uses or has applied for the following trademark: HydroSet

Literature Number: 90-07901

LOT B1008

Handling Characteristics

HydroSet is quick-setting and easy to mix and deliver via hand application or

syringe injection.

Mixing Time: 45 seconds

Transfer Time: 1 min 45 seconds

Injection and Sculpting Time: 2 minutes

Setting Time: 4 minutes 30 seconds at 32°C defect site temperature

Caution:

HydroSet is temperature sensitive, therefore, handling times are approximate

based on product and OR temperatures of 18 to 22°C (approx. 64−72°F).

A higher temperature can lead to a shorter setting

Copyright © 2008 Stryker


Features & Benefits

Indications

Indications

Rationale

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 applications.

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 match 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.

Enhanced screw fixation in cancellous bone at and after the

time of surgery*

Injecting HydroSet into cancellous bone creates a composite of bone and cement

that helps increase screw pull-out strength.

*This indication is not cleared for use in USA.

HydroSet is an injectable bone substitute intended to use for a wide variety of

clinical applications in multiple surgical specialties.

Distal Radius Void Filling

Tibia Plateau Void Filling

Tibia Pilon Void Filling

Note: Screw fixation must be provided by bone.

1. HydroSet is indicated to fill bone 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 bone voids or gaps that are not intrinsic to the stability of

the bone structure. HydroSet cured in situ provides an open void/gap filler that

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.

2. The cured cement enhances screw fixation in cancellous bone at and after the

time of surgery. Injecting HydroSet into cancellous bone creates a composite of

bone and cement; this is referred to as Bone Augmentation, and results in better

fixation of screws.*

*This indication is not cleared for use in USA.

Note: Always refer to the IFU as well before using HydroSet.

Warning:

HydroSet should not be used in areas where the surrounding bone is osteoporotic,

avascular or otherwise not capable of supporting or anchoring the implant.

Caution:

• Insertion of screws in hardened cement must be done in a controlled manner

(slowly drilling at

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