EC
REP
Emergo Europe
614 East 3900 South
Salt Lake City, UT 84107 U.S.A.
Tel+1.801.261.2236
Toll Free (US) (877) 261.2236
Fax +1.801.261.0573
www.innovasis.com
Molenstraat 15
2513 BH The Hague
The Netherlands
Tel: +(31) (0) 70 345-8570
Fax: +(31) (0) 70 346-7299

0459
Innovasis® Cranial System – Package Insert
DESCRIPTION:
The Innovasis® Cranial System consists of medical grade titanium implants (screws, plates, mesh) and accompanying instruments.
The plates are offered in a variety of shapes and sizes intended for reconstruction, stabilization and/or rigid fixation of non loadbearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). The
plates and mesh can be cut and bent to the appropriate size and shape. A selection of self-drilling/self-tapping screws are included
to provide adequate anchorage into the bone to ensure implant remains stable and immobile.
Innovasis Cranial System Bone Plates are made from 0.6mm thick pure Titanium (ASTM F67). Innovasis Cranial Bone Screws are
made from 6Al 4V (ELI) Titanium alloy (ASTM F136) with diameters of 1.6mm and 1.9mm and lengths from 3.0mm to 5.0mm. The
plates and screws are provided in a serialized tray or individually packaged, non-sterile and must be steam sterilized prior to use.
The Innovasis® Cranial System instruments are designed for cutting, bending, grasping and driving screws. The system comes in a
compact tray to allow for organization and autoclaving.
INDICATIONS FOR USE: This device is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive
procedures.
CONTRA-INDICATIONS FOR USE are as follows:
 Not for use in cases of active or suspected infection or in patients previously sensitized to titanium.
 Not for use in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation plate and
screw implants.
WARNINGS, PRECAUTIONS AND ADVERSE EFFECTS CONCERNING CRANIAL FIXATION IMPLANTS
POSSIBLE ADVERSE EFFECTS:
In many cases, adverse results may be clinically related rather than implant related.
 Osteoporosis, osteolysis, osteomyelitis, infection or inhibited revascularization and poor bone formation can cause
loosening, bending, cracking and fracturing of the device or premature loss of fixation with the bone, leading to nonunion.
 Delayed or nonunion, which may lead to breakage of the implant.
 Infection, early or late, both deep and/or superficial.
 Metal sensitivity reactions following surgical implant have rarely been reported, and their significance awaits further clinical
evaluation.
 Migration, bending, fracture or loosening of the implant.
 Metal sensitivity, or allergic reaction to foreign body
 Pain, discomfort, or abnormal sensation due to the presence of the device
 Increased fibrous tissue response around the facture site and/or the implant
 Necrosis of bone
 Inadequate healing
WARNINGS:

U.S. Federal Law restricts this device to the sale by or on the order of a licensed physician or other qualified medical
professional.

Selection of plate and screw size must be carefully considered by the operating surgeon and should take into
consideration the quality of bone, bone type, functional loads exerted on bone(s), and post-operative patient compliance.

For sale and effective use, the surgeon should have specific training, experience, and thorough familiarity with the use of
cranial fixation and techniques.

The surgeon must exercise reasonable judgment when deciding which plate and screw type to use for specific indications.

Innovasis Cranial System plates & screws are not intended to endure excessive abnormal functional stresses. Repeated
bending may weaken the plate and result in implant fracture and failure.

Use of an undersized plate or screw in areas of high functional stress may lead to implant fracture and failure.

Plates and screws, wires and other appliances of dissimilar metals should not be used together in or near the implant site.
PRECAUTIONS:
GENERAL: The physician/surgeon should thoroughly review the Innovasis Cranial System Surgical Technique Guide L00023
before surgery. A copy of this guide is available at www.innovasis.com or by request via telephone, fax or e-mail. Contact
information appears at the heading of this document.
©2014 Innovasis Inc.
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L00024 Rev B
Explanted surgical implants must never be reused. This product is single use only. Even though a device appears undamaged, it
may have defects and internal stress patterns which may lead to premature failure.
The Innovasis Cranial System has not been evaluated for safety and compatibility in the MR environment. The Innovasis Cranial
System has not been tested for heating or migration in the MR environment. The safety of the Innovasis Cranial System in the MR
environment is unknown.
The physician should inform the patient of risks associated with surgery.
PRE-OPERATIVE: The implants and instruments must be cleaned and sterilized before use.


The surgeon must confirm that all necessary implants and instruments are on hand for the planned surgical construct. The
implant components should be handled and stored carefully and protected from any damage including corrosive
environments. They should be carefully unpacked and examined for damage.
Selection of plate and screw size must be carefully considered by the operating surgeon and should take into
consideration the quality of bone, bone type, functional loads exerted on bone(s), and post-operative patient compliance.
INTRAOPERATIVE: Breakage, slippage or mishandling of the instruments or implant components, such as sharp edges, may
cause injury to the patient or operative personnel.
POSTOPERATIVE: The patient must be adequately instructed as to the risks and limitations of the implant as well as
postoperative care and rehabilitation.
CAUTION:

Improper fixation of the plate and screw may result in the formation of a ridge.

Once applied, never reuse this device.

Always follow appropriate safety precautions.

Select the appropriately sized plate and screw for the patient.

Responsibility for proper selection of patients, adequate training, experience in the choice and placement of plate & screw
and the decision to leave or remove plate and screw postoperatively rests with the surgeon.

Delayed healing, nonunion or subsequent bone resorption or trauma may cause excessive stress on this device and
result in loosening or fracture.
MATERIAL SPECIFICATION: Pure Titanium (ASTM F67) / Titanium is biocompatible, corrosion-resistant and nontoxic. Titanium
is malleable, while maintaining high strength. Screws are manufactured out of Titanium 6AL-4V ELI which complies with ASTM
F136; plates and mesh are manufactured from commercially pure titanium per ASTM F67. INNOVASIS expressly warrants that
these devices are fabricated per material specifications. No other warranties express or implied, are made. Implied warranties of
merchantability and fitness for a particular purpose or use are specifically excluded.
Do not re-use or re-implant under any circumstances. Components of this system should not be used with components from any
other manufacturer.
CLEANING AND DECONTAMINATION: Implants are provided clean and ready for sterilization at the health care facility.
Detailed cleaning recommendations for the instruments are in the Innovasis Surgical Instrument Cleaning, Sterilization and Reuse
instruction LG01. A copy of this guide is available at www.innovasis.com or by request via telephone, fax or e-mail. Contact
information appears at the heading of this document.
All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of
the device.
STERILIZATION: The INNOVASIS® CRANIAL SYSTEM implants and instruments are supplied NON-STERILE. The
implants and instruments used in surgery MUST be sterilized by the hospital prior to use. FDA cleared wraps are recommended
for use with the sterilization tray. Remove all packaging materials prior to sterilization. Use the following set up:
 Remove the cover of the sterilization tray to reveal the Innovasis Cranial System Bone Plates & Screws.
 Remove the bone screw from its package using forceps. Handle bone plates with powder-free gloves and avoid contact
with hard objects that may damage the surface.
 Place the bone screw in the screw organizer disc. Place the bone plate in its designated area in the tray.
 After selecting the bone screw, turn the screw organizer cover so screws are retained.
 Prior to sterilization, wrap the tray with an FDA cleared surgical drape (such as Kimguard KC600) with two layers of 1-ply
polypropylene wrap using sequential envelope folding technique.
Only sterile products should be placed in the operative field. For a 10-6 Sterility Assurance Level, it is recommended that the
Innovasis Cranial System tray containing implants and instruments be steam sterilized by the hospital using one of the two sets of
process parameters below:
METHOD
Steam
Steam
CYCLE
Pre-vacuum (Wrapped)
Gravity Displacement
(Wrapped)
TEMPERATURE
2700 F (1320 C )
2700 F (1320 C )
EXPOSURE TIME
4 Minutes
15 Minutes
DRY TIME
20 Minutes
30 Minutes
It is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical
indicators, biological indicators, and sterilization cassettes) that have been cleared by the Food and Drug Administration for the
selected sterilization cycle specifications (time and temperature).
NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the
sterilization process (e.g. temperatures, times) used for their equipment.
CAUTION: Federal Law (U.S.A.) restricts these devices to sale by or on order of a physician.
©2014 Innovasis Inc.
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L00024 Rev B