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KLS Martin 91-600-04-57 · Rev 3 · 2021-08-26 · Longitudinal Sternal Stabilization (LSS) Technique Guide

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LSS
Longitudinal Sternal Stabilization
Technique Guide: Midline Closure
Developed in conjunction with Dr. Jeko Madjarov
and Carolinas Medical Center
www.klsmartinnorthamerica.com
Products shown may not be licensed or cleared in all markets. Availability is subject to change without notice.Licensed for US and CA.
One LSS plate (24-039-30-72) must be
placed on each sternal half to stabilize
the sternum. The straight edge of the
plate will be placed on the sternum
medially.
Explanation of icons
Screw diameter 2.3 mm
PEEK
2
Polyether Ether Ketone
Packaging unit
Sterile packaged
Plates are not designed for transverse
fracture fixation, rib-to-rib fixation or the
spanning of continuity defects.
/1
1
24-039-30-72
LSS plate
20.8 cm
PEEK
2
2
LSS Technique Guide: indications and contraindications
LSS
Longitudinal Sternal Stabilization
The LSS Plating System includes plates and screws that are intended to be used in conjunction with stainless
steel suture wire for midline sternal closure. The LSS plates, when applied, are used to reinforce the sternal
halves and mitigate the chance of sternal wire pulling through bone. The plates are manufactured from PEEK
and offered in one size. The thickness of each plate ranges from 2.1 mm – 2.5 mm (minimum – maximum
dimensions) and are fixated using 2.3 mm titanium screws. Once the sternum is reapproximated, the midline
is closed using circumferentially wrapped stainless steel suture wires. Emergent re-entry is accomplished
by cutting the stainless steel suture wire.
Indications for Use:
The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary
or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal
halves and distribute wire tension.
Contraindications:
1. Active infection.
2. Fracture fixation.
3. Patients with sternal anomalies that prevent proper placement of the device, blood supply limitations,
insufficient quantity or quality of bone, severe osteoporosis, bone tumors in implant region or latent
infection.
4. Patients with mental, physical, neurological or other conditions who are unwilling or incapable of
following postoperative care instructions.
5. Foreign body sensitivity: Where material sensitivity is suspected, testing is to be completed prior to
implantation.
6. Patients that are still growing.
3
LSS Technique Guide: implantation
Implantation
Step 1:
Expose
Step 2:
Plate length
Dissect the soft tissue from the surface of the anterior sternum to allow
for complete visualization of the bone. This step should also be performed
in revision cases that require wire removal due to sternal nonunion or for
re-operation.
Check the plate length, cut if necessary.
Place the plate on the anterior surface of the sternum to ensure proper length.
If the plate is too long, use the Wire/Plate Cutter (22-523-22-07) to cut to the
desired length. The recommended length should cover the entire vertical length
of the sternal half from the manubrium to the xiphoid.
The surgeon must check the sternal halves to ensure adequate bone quality and
quantity for bone screw fixation.
Wire / plate cutter
4
Step 3:
Measure
Step 4:
Select
Measure the depth of the sternum at the anticipated screw hole locations before
bone reduction to ensure the selection of appropriate screws. Use the Sternal
Caliper (24-006-01-07) to determine sternum thickness.
Select one LSS plate. Place the plate vertically on one sternal half. The straight
edge of the plate should be positioned toward the midline. The lateral edge of
the plate should lie at the lateral edge of the sternum or more to the rib side to
ensure proper wire placement.
Screws should be no longer than necessary to engage the posterior
cortex. The surgeon should use extreme care to ensure the screw does not
extend past the posterior surface.
Do not use a screw that is longer than the measured thickness of the sternum.
For example: If the sternum is 13 mm thick, use a 13 mm screw. If the sternum
is 12 mm thick, use an 11 mm screw.
Once the plate is in the desired location, select the appropriate length 2.3 mm
maxDrive Sternal screw based on the recorded measurements. Place the screw
in the desired screw hole by using the maxDriver (KLS-SD-1000) or screwdriver
handle (25-407-01-07) and blade (25-486-97-07). The plate should be fixed by
placing the screws in order, moving superior to inferior. The plate should be
adapted with digital pressure during fixation to ensure the best possible contour.
x a
0
20
17
14
11
10
20
30
40
Caliper
maxDriver
Screwdriver
handle
Screwdriver
blade
5
LSS Technique Guide: implantation
Step 5:
Secure
Step 6:
Reduce
The screw should be inserted by turning in a clockwise direction. The screw will
lock into the plate. Screw placement is complete once the screw is fully engaged
and the screw head is one full turn below anterior surface of the plate.
Once the plates are appropriately fixed to each hemisterna, place monofilament
stainless steel wires circumferentially around the sternum and over the plates.
Note: Avoid over-tightening the screw once it is completely engaged into the
plate. Screws should be placed in all holes of the plate.
If screws are placed with the maxDriver (KLS-SD-1000), the surgeon should use
the screwdriver handle (25-407-01-07) and blade (25-486-97-07) after screw
placement to ensure the screws are completely locked into the plate. Screws may
require additional tightening.
The surgeon should use a simple, interrupted cerclage wire closure technique
to approximate the sternal halves in the traditional manner. Wires should be
tightened by tactile feel in the same method as for a wire-only closure. The
surgeon should choose the correct number and placement of wires to ensure
a proper closure. A minimum of eight (8) stainless steel suture wires with a
diameter of 0.9 mm is recommended in conjunction with the plate.
Repeat these steps to place the remaining plate.
Note: The LSS plate is intended only to support the underlying bone and help
mitigate wire pull through. The use of the LSS plate is not intended to change
the method of wire closure that the surgeon would typically choose based on
the patients specific needs.
Plates should not be placed over transverse fractures. Do not place
screws with more than 3o of angulation.
Wires should be placed over convex area only. Do not place over a
screw hole.
Prior to sternal approximation, the surgeon should visually and digitally check
the posterior table of the sternum to ensure a screw has not penetrated the
posterior cortex as described in Step 3.
maxDriver
6
Screwdriver
handle
screwdriver
blade
Step 7:
Emergent Re-entry
Step 8:
Long-term Removal (if necessary)
If emergent reentry is necessary, the wire can be cut with most wire cutters found
in the operating room or crash cart.
Cut and remove the wires.
Remove all screws.
After re-entry, the sternum can be reapproximated using the method in Step 6.
Remove plates and dispose.
Do not reuse implants.
Wire / plate cutter
7
LSS Technique Guide: s crews, twist drills, and screwdrivers overview
LSS
Screws, twist drills, and screwdrivers
Ø 2.3 mm
Drill-Free maxDrive
Sternal Screws
Locking
Self-retaining
Ø 1.9 mm
Twist Drills
Ø
Length
5
7 mm
24-023-07-09
24-023-07-91
50 mm
–
25-458-19-07
9 mm
24-023-09-09
24-023-09-91
70 mm
7 mm
25-460-07-07
11 mm
24-023-11-09
24-023-11-91
70 mm
9 mm
25-460-09-07
13 mm
24-023-13-09
24-023-13-91
70 mm
–
25-460-19-07
15 mm
24-023-15-09
24-023-15-91
17 mm
24-023-17-09
24-023-17-91
Length
Stop
KLS-BP-001
Battery pack for
KLS-SD-1000
8
Explanation of icons
Screw diameter 2.3 mm
Steel
Titanium
J-Notch
maxDrive
Packaging unit
Sterile packaged
Ø 2.0/2.3 mm
Blades
suitable for
Screwdrivers and Blades
25-407-01-07
25-410-00-07
25-411-00-07*
Ratchet
Ratchet, flattened
KLS-SD-1000
50-817-20-07
50-817-20-07
25-486-97-07
25-486-98-07
X
25-486-97-07
X
X
X
25-486-98-07
X
X
X
*For storage in Level One modules
9
LSS Technique Guide: instrumentation
LSS
Instrumentation
0
10
20
30
40
½
½
50-501-40-07
Depth gauge
12-188-17-07
Cushing forceps
24-006-01-07
Caliper
17 cm, 6 1/2”
serrated
17 cm, 6 3/4”
20
17
14
11
10
½
Explanation of icons
Steel
Packaging unit
Tungsten Carbide
inserts
½
½
22-523-22-07
Wire / plate cutter
50-205-16-07
Plate holding forceps
22 cm, 8 3/4”
11
KLS Martin Group
KLS Martin Australia Pty Ltd.
Sydney · Australia
Tel. +61 2 9439 5316
australia@klsmartin.com
KLS Martin do Brasil Ltda.
São Paulo · Brazil
Tel. +55 11 3554 2299
brazil@klsmartin.com
KLS Martin Medical (Shanghai) International Trading Co. Ltd.
Shanghai · China
Tel. +86 21 5820 6251
china@klsmartin.com
Gebrüder Martin GmbH & Co. KG
Tuttlingen · Germany
Tel. +49 7461 706-0
info@klsmartin.com
KLS Martin India Pvt Ltd.
Chennai · India
Tel. +91 44 66 442 300
india@klsmartin.com
Martin Italia S.r.l.
Milan · Italy
Tel. +39 039 605 67 31
italia@klsmartin.com
Nippon Martin K.K.
Tokyo · Japan
Tel. +81 3 3814 1431
nippon@klsmartin.com
KLS Martin SE Asia Sdn. Bhd.
Penang · Malaysia
Tel. +604 505 7838
malaysia@klsmartin.com
KLS Martin de México S.A. de C.V.
Mexico City · Mexico
mexico@klsmartin.com
Martin Nederland/Marned B.V.
Huizen · The Netherlands
Tel. +31 35 523 45 38
nederland@klsmartin.com
Gebrüder Martin GmbH & Co. KG
Moscow · Russia
Tel. +7 499 792-76-19
russia@klsmartin.com
KLS Martin Taiwan Ltd.
Taipei · Taiwan
Tel. +886 2 2325 3169
taiwan@klsmartin.com
Gebrüder Martin GmbH & Co. KG
Dubai · United Arab Emirates
Tel. +971 4 454 16 55
middleeast@klsmartin.com
KLS Martin UK Ltd.
London · United Kingdom
Tel. +44 1189 000 570
uk@klsmartin.com
KLS-Martin L.P.
Mail:
P.O. Box 16369
Jacksonville, FL 32245-6369
Office: 11201 Saint Johns Industrial Pkwy S.
Jacksonville, FL 32246-7652
Tel.
904.641.7746 · 800.625.1557
Fax
904.641.7378
usa@klsmartin.com · www.klsmartinnorthamerica.com
91-600-04-57 · Rev 3 · 2021-08-26 · LSS Technique Guide · The information presented is intended to demonstrate a KLS-Martin L.P. product. Please refer to the IFU for the full list of indications, contraindications,
warnings, precautions, and sterilization information. Always refer to the IFU before using any KLS-Martin L.P. product. Surgeons must always rely on their own clinical judgment when deciding which products and
techniques to use with their patients.
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