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ClearFix Rigid Sternal Fixation

Distributed by ClearFlow Distribution Company

About ClearFix

The ClearFix Rigid Sternal Fixation is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to promote fusion.

Details

Key Benefits

Rigid Fixation

Rigid sternal fixation is preferable to wire fixation because plates ensure a secure closure that won’t allow movement.
Studies have demonstrated significant reductions of sternal wound complications for patients who received rigid sternal fixation.

Using rigid sternal fixation is cost neutral and provides patients more rapid return to mobility, there is less pain and less need for extended care after discharge.

Star-Shaped Screw

Requires less rotational torque than hex screws and less wear of camming-out.
Provides better grip on pickup for added maneuverability and precise placement.
Proprietary design ensures the driver sits in the screw head securely without falling.

Self-Drilling Screw

Extremely sharp point allows screws to go directly into bone without pre-drilling.
Saves time and allows for a swift closure which can be critical.
Screw pull-out force is significantly higher than FDA guidance for a secure closure—provides 67 percent more pullout strength.

Plate Structure

Thin, double-sided plates allow for either side to go against the bone.
Easy use reduces closure time and simplifies plate placement.
ClearFix plates are thinner than some other options on the market at 1.6mm – for a more
comfortable fit on the chest.

Tray

Compact and light-weight tray made of durable PP plastic takes up less space and is easier for the operating team to hold and carry.
Additional compartment keeps everything organized and gives convenient space to secure unused pieces.
ClearFix provides only necessary instruments to keep the kit compact and customizable.

Methods

Surgical Technique

1
Measuring Sternal Depth

Measure sternal depth where plate placement will occur. Measure at 3 points (manubrium, body and xiphoid). In the photo, the measuring device indicates that a 14 mm screw length would be recommended for plate placement. The measuring device accounts for the thickness of the plate, so a 14 mm screw would be used in this example.

*Note, if using a standard ruler to measure the thickness of the sternum, you should use the next highest even numbered length screw to account for the plate thickness. For example a sternal thickness of 8 mm - 9 mm should utilize a 10 mm screw, while a sternal thickness of 10 mm - 11 mm should use a 12 mm screw. Surgeons should always determine screw size based on the patient’s anatomy.
2
Bone Reduction and Plate Positioning

Wire the manubrium and xiphoid to reduce the top and bottom of the sternum. Complete the full approximation by placing reduction forceps at the mid-body.
3
Fixation of the Plate

Plates are two-sided to facilitate placement. If necessary, bend the plate to match the shape of the bone.

Insert screws into the plate. Using the Power Driver for screw insertion is recommended for quick and efficient surgery.

Fully tighten once additional screws are in place by using the screw driver handle.

Ordering Information

Plates

**CF-24-LPST-004**
L
4 Holes
1.6 mm
Gold

**CF-24-HSST-008**
X
8 Holes
1.6 mm
Gold

**CF-24-SQST-004**
Square
4 Holes
1.6 mm
Gold

**CF-24-JLST-008**
JL
8 Holes
1.6 mm
Gold

**CF-24-STST-004**
Straight
4 Holes
1.6 mm
Gold

**CF-24-HNST-012**
Ladder, Narrow
12 Holes
1.6 mm
Gold

**CF-24-STST-008**
Straight
8 Holes
1.6 mm
Gold

**CF-24-HWST-012**
Ladder, Wide
12 Holes
1.6 mm
Gold

**CF-24-HSST-008**
Ladder, Short
8 Holes
1.6 mm
Gold

Screws

Ø 2.4 Locking Screws

Code	Length	Color	Set Quantity
CF-24L-SA-S08-TA	8 mm	Silver	7
CF-24L-SA-S10-TA	10mm	Silver	7
CF-24L-SA-S12-TA	12mm	Silver	14
CF-24L-SA-S14-TA	14mm	Silver	14
CF-24L-SA-S16-TA	16mm	Silver	14
CF-24L-SA-S18-TA	18mm	Silver	7
CF-24L-SA-S20-TA	20mm	Silver	7

Ø 2.7 Locking Screws

Code	Length	Color	Set Quantity
CF-27L-SA-S08-TA	8mm	Gold	4
CF-27L-SA-S10-TA	10mm	Gold	4
CF-27L-SA-S12-TA	12mm	Gold	8
CF-27L-SA-S14-TA	14mm	Gold	8
CF-27L-SA-S16-TA	16mm	Gold	8
CF-27L-SA-S18-TA	18mm	Gold	4
CF-27L-SA-S20-TA	20mm	Gold	4

Instruments

Handle

Code	Description	Set Quantity
CF-111-151	Screw Driver Handle	1

Plate Bender

Code	Description	Set Quantity
CF-26.0240.17	Plate Bender	2

Plate Cutter

Code	Description	Set Quantity
CF-111-156	Plate Cutter	1

Bone Reposition Forcep

Code	Description	Set Quantity
CF-111-154	Bone Reposition Forcep (Large)	2
CF-111-155	Bone Reposition Forcep	2

Depth Gauge

Code	Description	Set Quantity
CF-111-148	Depth Gauge (Mid)	1
CF-111-149	Depth Gauge (Left)	Optional
CF-111-150	Depth Gauge (Right)	Optional

Driver

Code	Description	Set Quantity
CF-113-HF-613	Driver for T8 Ф3 Standard 70mm Ball	1
CF-113-HF-624	Driver for T8 Ф3 Standard 50mm Ball	1

Forceps

Code	Description	Set Quantity
CF-111-038	Plate Holding Forcep	1
CF-114-009	Plate Holding Forcep	1

Power Driver

Code	Description	Set Quantity
CF-111-ED-050	Torque 45Ncm, 210 RPM	Optional
CF-111-ED-051	Torque 40Ncm, 165 RPM	Optional

Kit

Code	Description	Set Quantity
CF-112-107	ClearFix Sternal System Kit (Includes Inner Tray)	1

Plates

CF-24-LPST-004

4 Holes

1.6 mm

Gold

CF-24-XPST-008

8 Holes

1.6 mm

Gold

CF-24-SQST-004

Square

4 Holes

1.6 mm

Gold

CF-24-JLST-008

8 Holes

1.6 mm

Gold

CF-24-STST-004

Straight

4 Holes

1.6 mm

Gold

CF-24-HNST-012

Ladder, Narrow

12 Holes

1.6 mm

Gold

CF-24-STST-008

Straight

8 Holes

1.6 mm

Gold

CF-24-HWST-012

Ladder, Wide

12 Holes

1.6 mm

Gold

CF-24-HSST-008

Ladder, Short

8 Holes

1.6 mm

Gold

Screws

Ø 2.4 Locking Screws

Code	Length	Color	Set Quantity
CF-24L-SA-S08-TA	8 mm	Silver	7
CF-24L-SA-S10-TA	10mm	Silver	7
CF-24L-SA-S12-TA	12mm	Silver	14
CF-24L-SA-S14-TA	14mm	Silver	14
CF-24L-SA-S16-TA	16mm	Silver	14
CF-24L-SA-S18-TA	18mm	Silver	7
CF-24L-SA-S20-TA	20mm	Silver	7

Ø 2.7 Locking Screws

Code	Length	Color	Set Quantity
CF-27L-SA-S08-TA	8mm	Gold	4
CF-27L-SA-S10-TA	10mm	Gold	4
CF-27L-SA-S12-TA	12mm	Gold	8
CF-27L-SA-S14-TA	14mm	Gold	8
CF-27L-SA-S16-TA	16mm	Gold	8
CF-27L-SA-S18-TA	18mm	Gold	4
CF-27L-SA-S20-TA	20mm	Gold	4