Cranial System. Neuro Plating and Screw System
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1 Cranial System Neuro Plating and Screw System
2 Innovasis Cranial System INDICATIONS FOR USE The Innovasis Cranial System (ICS) is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures. WARNING: 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 rigid 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. 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. The Innovasis Cranial System implants are manufactured from implant grade materials that are nonferromagnetic. 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, migration or image artifact in the MR environment. The safety of the Innovasis Cranial System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. PRODUCT OVERVIEW The Innovasis Cranial System Bone Plates are comprised of a variety of shapes and sizes intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). ICS is a simple yet comprehensive system that offers flexibility and ease of use. All screws are compatible with each ICS plate. One driver for all screws within the system. Reduced plate/screw profile. Standardized instrumentation. INNOVASIS Cranial System Guide / PG 2
3 IMPLANT OVERVIEW INNOVASIS CRANIAL PLATING SYSTEM Low plate/screw profile of 0.6mm Self-drilling screws for fast closure of bone flaps and rapid fixation of cranial fractures. Wide variety of screws, plates and mesh allow the surgeon to select the most appropriate implants based on patient needs. ICS SELF-DRILLING SCREWS Unique thread design for rapid screw insertion. Available in 1.6mm and 1.9mm diameters and lengths of 3.0mm, 4.0mm and 5.0mm. ICS PLATES Full selection of titanium plates and burr hole covers. ICS CONTOURABLE MESH Available in 100 x 100mm size. INNOVASIS Cranial System Guide / PG 3
4 INSTRUMENTS OVERVIEW LS-266 Cranial Fixation Driver Assembly LS-268 Cranial Fixation Plate Cutter LS-270 Cranial Fixation Driver Shaft LS-267 Cranial Fixation Plate Bender LS-269 Cranial Fixation Grasping Forceps INNOVASIS Cranial System Guide / PG 4
5 SELECT IMPLANT Select the appropriate implants base on the patient needs. The Innovasis Cranial System offers a wide variety of plates, burr hole covers, mesh and screws. SIZE & CONTOUR IMPLANT (IF REQUIRED) The implants may be cut and sized to match patient anatomy and the needs of the specific case. Cut the implants immediatlely adjacent to screw holes. Note: Take care to protect soft tissue from trimmed edges. The plates are very malleable - finger pressure is sufficient to bend and contour. The outer segments of all plates can be bent and contoured using bending forceps. Note: Avoid bending across any screw holes. Excessive bending of the implant increases the risk of implant breakage. The hole to hole spans have been designed to allow the bending forceps to grip the plate between the inter-hole segments. INNOVASIS Cranial System Guide / PG 5
6 POSITION IMPLANT Position the implant on the desired location using the appropriate plate holder. Note: Most of the plates and meshes have a screw recess on one side only. Position all plates with the recess facing away from the bone for proper screw insertion. INNOVASIS Cranial System Guide / PG 6
7 PRE-DRILL SCREW HOLES (OPTIONAL) Innovasis Cranial System bone screws that are 1.6mm in diameter are self-drilling and self-tapping. It is not necessary to pre-drill the holes, though pre-drilling may be performed at the discretion of the surgeon. Innovasis Cranial System bone screws that are 1.9mm in diameter are self-tapping only and should be inserted into an existing or predrilled hole for use as a rescue screw. Innovasis recommends pre-drilling in dense bone and/or when using the 5mm screws. Note: Do not exceed 1800 rpm while drilling. Proper irrigation should also be used. INNOVASIS Cranial System Guide / PG 7
8 SECURE IMPLANT The driver shaft features a cruciform tip that friction fits into the head of the screw. Fully engage the shaft perpendicular to the screw head to affix the screw to the shaft. Place the self-drilling screw perpendicular to the bone at the appropriate plate hole. Take care not to over tighten the screw. Use the appropriate number of plates and screws to achieve the required stability. INNOVASIS Cranial System Guide / PG 8
9 TECHNIQUE TIP Secure the implants to the bone flap before positioning the bone flap on the patient. INNOVASIS Cranial System Guide / PG 9
10 IMPLANTS Screws ITEM PART NO. DESCRIPTION STD QTY 1 C5SD x 3mm SELF-DRILLING/SELF-TAPPING BONE SCREW 20 2 C5SD x 4mm SELF-DRILLING/SELF-TAPPING BONE SCREW 20 3 C5SD x 5mm SELF-DRILLING/SELF-TAPPING BONE SCREW 20 4 C5SS x 4mm SELF-TAPPING BONE SCREW 4 Plates ITEM PART NO. DESCRIPTION STD QTY 5 C2ST HOLES, STRAIGHT PLATE 4 6 C2ST HOLES, STRAIGHT PLATE, LONG 4 7 C2DY HOLES, DOUBLE Y-PLATE 4 8 C2SQ HOLES, SQUARE PLATE 4 9 C2ST HOLES, STRAIGHT PLATE 4 10 C2ST HOLES, STRAIGHT PLATE 4 11 C2BR HOLES, 15mm DIA., BURR HOLE PLATE 4 12 C2BR HOLES, 15mm DIA., BURR HOLE PLATE W/SHUNT 4 13 C2BR HOLES, 22mm DIA., BURR HOLE PLATE 4 14 C2BR HOLES, 22mm DIA., BURR HOLE PLATE W/SHUNT 4 15 C3DM06100 DYNAMIC MESH, 0.6mm X 100mm 4 INNOVASIS Cranial System Guide / PG 10
11 INSTRUMENTS ITEM PART NO. DESCRIPTION STD QTY 16 LS-266 CRANIAL FIXATION DRIVER ASSEMBLY 2 17 LS-267 CRANIAL FIXATION PLATE BENDER 1 18 LS-268 CRANIAL FIXATION PLATE CUTTER 1 19 LS-269 CRANIAL FIXATION GRASPING FORCEPS 1 20 LS-270 CRANIAL FIXATION DRIVER SHAFT 2 INNOVASIS Cranial System Guide / PG 11
12 M Innovasis, Inc. 614 East 3900 South Salt Lake City, UT Tel: Tel: Fax: Info@Innovasis.com L00023 REV F
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