l law (USA) restricts this device to sale by
or on the order of a physician.
Read and understand all the information in these
instructions. If you have any questions, contact
your Stryker sales representative or customer
service at 1-866-476-2663.
Description:
Calstrux bone void filler is an absorbable bone
void filler for the repair of bony defects. It is an
osteo-conductive resorbable implant composed of
tricalcium phosphate granules and a putty
additive. The implant structure resembles the
multidimensional porosity of human cancellous
bone, and acts as a scaffold for the ingrowth of
new bone and other connective tissues. The putty
consistency allows the shape of the implant to
conform to the defect, maximizing direct contact
with viable host bone. This contact is important
for new growth into the scaffold as the implant is
absorbed.
Intended Use and Indications:
Calstrux bone void filler is indicated as a bone
void filler for voids or gaps that are not intrinsic
to the stability of the bony structure. It is indicated
for surgically created osseous defects or osseous
defects resulting from traumatic injury. It should
not be used to treat large defects that in the
surgeon's opinion would fail to heal
spontaneously.
Calstrux bone void filler is intended to be gently
packed into bony voids or gaps of the skeletal
system (i.e. extremities, spine and pelvis).
Following placement in the bony void or gap, the
tri-calcium phosphate scaffold is resorbed and
replaced with bone during the healing process.
Contraindications:
Calstrux bone void filler is not designed or sold
for any use except as indicated. Do not use
Calstrux bone void filler in the presence of any
contraindication.
Contraindications include but are not limited to:
use in a patient with any known sensitivity to
components of the TCP or CMC;
use in infected sites;
use in sites subject to excessive impact or
stress;
use in areas with significant vascular
impairment proximal to the graft site;
use in direct contact with the articular space;
presence of growth plate fractures;
presence of segmental defects;
use in patients having metabolic or systemic
bone disorders that affect bone or wound
healing.
Warnings:
Calstrux bone void filler does not possess
significant mechanical strength to support
reduction of a defect site. Rigid fixation
techniques are recommended as needed to assure
stabilization of the defect in all planes.
Calstrux bone void filler cannot be used to obtain
purchase for screws; screws must first gain
purchase in the host bone. Single use only. Do not
resterilize. Do not use if packaging is damaged.
Precautions:
Calstrux bone void filler is intended for use
only by surgeons familiar with bone grafting
and fixation techniques.
Aseptic handling techniques are required during
all phases of device handling.
Complete postoperative wound closure is
essential. Calstrux bone void filler must not be
used to repair bone defects where soft tissue
coverage cannot be achieved.
Calstrux's radiopacity is comparable to that of
bone and diminishes as it is absorbed. This
moderate radiopacity may mask underlying
pathological conditions and must be considered
when evaluating radiographs.
Calstrux bone void filler should be used precisely
as directed. Do not exceed total liquid advised or
over-fill the defect site with Calstrux bone void
filler. The volume of Calstrux bone void filler
used should approximate the size of the defect
since over-filling the defect site may create a risk
of Calstrux bone void filler migration. In addition,
Calstrux bone void filler should not be used in
combination with other products.
Adverse events including localized induration,
swelling, inflammation, wound drainage,
infection, and device migration have been
reported when Calstrux bone void filler has been
used in such combination.
The effect of Calstrux bone void filler on
patients with the following is not known:
Documented renal disease;
Metabolic bone disease;
Pregnancy/nursing;
Defects due to disease or congenital
malformation;
Cardiovascular disease precluding elective
surgery;
Infection during the last three months;
Past or future radiation therapy at or near the
implant site;
Any systemic condition that affects the normal
healing of bone.
Adverse Events:
The occurrence of any of the following
complications is possible and may require re-
operation and/or removal of the implant.
Complications may include but are not limited to:
superficial or deep wound infection
deep wound infection with osteomyelitis
nonunion, malunion, or delayed union
wound dehiscence
loss of reduction
refracture
cyst recurrence
hematoma
cellulitis
How Supplied:
Calstrux bone void filler is supplied sterile in
granular form. It is a single-use device available
in a range of volumes from 5 to 15 cc vials.
Sterilization:
Calstrux bone void filler is supplied sterile by
prior exposure to gamma radiation. Calstrux bone
void filler cannot be resterilized by any method.
Excess material and unused material from an open
vial must be discarded.
Inspect the packaging of any sterile product for
structural integrity prior to use. If the seal of any
inner or outer container is broken or damaged, the
product must be assumed to be nonsterile.
Instructions for Use:
1. Empty the entire contents of the
vial into a small sterile mixing
bowl. Blend the dry powder with a
sterile spatula to achieve a uniform
mixture of the components in
Calstrux bone void filler.
2. Add sterile saline or water
according to the following table:
3. Using a sterile spatula, mix the
contents of the bowl by first
wetting out the dry powder and
then compressing the material
against the side of the bowl.
Continue to completely press
against the side of the bowl until
uniformly-blended dough is
formed.
Note: There should be no clumps of
dry powder or granules in the
mixture or at the bottom of the
bowl.
4. Remove the entire mixture from
the bowl and knead between
fingers. Continue to knead the
mixture to achieve a single
uniform mass that has a firm
putty-like consistency with
optimal handling characteristics.
Note: When prepared correctly, the
material will not leave a sticky mass
on gloves or have a crumbly
appearance.
5. Mold the material to the desired
shape. The product is ready for
implanting.
6. Provide adequate hemostasis before
implanting Calstrux bone void filler. Suction
and irrigate the surgical site as necessary prior
to implantation of Calstrux bone void filler
and ensure the site is as dry as possible.
Where practical, Calstrux bone void filler
should be implanted immediately prior to soft
tissue closure.
7. Gently fill the defect site, making contact with
as much viable host bone as possible. Be
careful not to over-pack the site.
8. Close the soft tissues surrounding the defect
containing Calstrux bone void filler using
suture material of choice. Closure is critical
for containment and maintenance of Calstrux
bone void filler at the defect site.
Calstrux bone void filler is not intended for use in
load-bearing applications. Anatomical reduction
and rigid fixation in all planes is required.
Warranty:
Suitability for use of the medical device for any
surgical procedure shall be determined by the
health care provider. Stryker shall not be liable for
incidental or consequential damages of any kind.
Returns:
Contact Stryker. All returns require a returned
material authorization (RMA) number. Open
products cannot be returned for credit.
Symbol Definitions:
US Patent No.: 6,949,251
Volume of Calstrux
bone void filler
Liquid
5 cc
3 cc
10 cc
6.5 cc
15 cc
9 cc
Distributed by:
Stryker Biotech
35 South Street
Hopkinton, MA 01748
Ph: 1-866-476-2663
Manufactured by:
Howmedica International
S. de R.L.
Raheen Business Park
Limerick, Ireland
080000138 Rev. 5
STERILE ONLY IF
PACKAGE IS UNOPENED
AND UNDAMAGED.
SINGLE USE ONLY.
DO NOT REUSE OR
RESTERILIZE.
SEE INSTRUCTION USE
STERILE BY IRRADIATION.
USE BY.
CATALOGUE
NUMBER.
LOT NUMBER