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