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SURGICAL TECHNIQUE
TABLE OF CONTENTS
Slimplicity® Anterior Cervical
Plate System Overview
2
Overview of System
2
Indications
2
Implants
3
Instruments
4
Surgical Technique
6
1. Patient Positioning and Approach
6
2. Plate Selection
6
3. Plate Contouring
6
4. Plate Positioning
6
5. Temporary Pin Placement
7
6. Preparing Screw Hole
7
7. Screw Insertion
8
8. Locking Mechanism
8
9. Closure
9
10. Screw Removal
9
Product Information
10
Instruments
10
Implants
10
SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM OVERVIEW
®
The Slimplicity Anterior Cervical Plate System offers one
of the slimmest plates available with an easy to use locking
mechanism that facilitates visual locking confirmation.
Large graft windows have been incorporated to provide
unimpeded graft site and end plate visualization. The large
array of variable and fixed screw options accommodate
semi-constrained, constrained and hybrid philosophies,
while the plates are pre-contoured to address varying
patient anatomy in single and multi-level constructs.
Indications
The Slimplicity Anterior Cervical Plate System is indicated
for use in temporary stabilization of the anterior spine from
C2 to T1 during the development of cervical spinal fusions
in patients with: degenerative disc disease (DDD)
(as defined by neck pain of discogenic origin with
degeneration of disc confirmed by patient history and
radiographic studies); spondylolisthesis; trauma (including
fractures or dislocations); spinal tumors; spinal stenosis;
pseudarthrosis; and failed previous fusions.
Please refer to package insert (LBL-IFU-005) for complete
system description, indications and warnings.
2
IMPLANT FEATURES
Slimplicity® Plates
• Low Profile Plate (2mm) designed to minimize tissue
disruption and post-op discomfort (Figure 1)
• Pre-Contoured to address patient anatomy (Figure 1)
• Central Graft Windows facilitate unimpeded graft
visualization (Figure 2)
• Intuitive Single Step Locking Mechanism facilitates
secure application (Figure 3)
Plate Sizing
Lengths
1 Level – 7 sizes, 20-34mm (2mm increments)
2 Level – 7 sizes, 35, 37-55mm (3mm increments)
3 Level – 8 sizes, 54-75mm (3mm increments)
4 Level – 6 sizes, 69-89mm (4mm increments)
Width 17mm
Figure 1
Figure 2
Waist 14mm
Slimplicity Fixed & Variable Bone Screws
Variable Screws have a 14° (4.5mm) or 20° (4.0mm)
cone of angulation to accommodate preferred screw
placement (Figure 4)
Fixed & Variable Screw Sizes
4.0 & 4.5mm Diameters
12-18mm Lengths (2mm increments)
Figure 3
20°
(4.0mm)
20°
(4.0mm)
Figure 4
3
INSTRUMENTS
ACP Plate Bender
• Used to create a lordotic or kyphotic bend in the
Slimplicity Plate
®
• Part Number ACP-003
ACP Bone Awl
• Used to create a starter hole for the Slimplicity Drills
• Part Number ACP-006
ACP Fixation Pin
Note: Not for definitive fixation
• Used to hold the Plate in position during Screw
placement
• Part Number ACP-009
ACP Fixed Drill Guide
• Used as a guide for the ACP Drill when utilizing a
Fixed Screw
• Part Number ACP-005F
ACP Variable Drill Guide
• Used as a guide for the ACP Drill when utilizing a
Variable Screw
• Part Number ACP-005V
4
ACP Drill Universal Straight Handle
Shown assembled with ACP Drill Guide and
16mm ACP Drill
• Used with the ACP Drills
• Part Number 04-9024
ACP Drills
• Used to prepare a pathway in bone for the
Bone Screws
• Part Number ACP-012 (12mm) Purple
• Part Number ACP-014 (14mm) Gold
• Part Number ACP-016 (16mm) Green
ACP 2.5mm Tapered Hex Driver
• Used to advance Bone Screws through the
Slimplicity Plate and secure them to bone
®
• Part Number 00-9027
ACP Locking Tool
• Used to prevent Bone Screw backout by engaging
the locking mechanism
• Part Number 00-9021
ACP Lock/ Unlock Tool
• Used to prevent Bone Screw backout by engaging
the locking mechanism or unlocking the locking
mechanism for removal of the Bone Screw
• Part Number 00-9023
5
SURGICAL TECHNIQUE
1. Patient Positioning and Approach:
The patient is placed on the operating room table in
the supine position with the head in slight extension
and slight rotation opposite the side of incision. After
decompression and interbody grafting procedures
have been completed, remove all anterior osteophytes
to provide a contoured contact surface for optimum
plate positioning.
2. Plate Selection:
When selecting the Plate size that best fits the anatomy,
it is important to know that the length of the Plate is
based on the distance between the ends of the Plate.
The Plate should not extend over the adjacent disc
spaces.
3. Plate Contouring:
The Slimplicity Anterior Cervical Plate is precontoured with lordotic curvature to minimize intraoperative contouring. If the lordotic curvature of the
Plate needs to be modified, the Plate Bender may
be used for contouring. The Plate should not be
contoured through the locking mechanism as it
could become damaged.
®
4. Plate Positioning:
Position the Plate over the vertebral bodies to
be instrumented using a plate holder. Confirm the
Plate is properly aligned in mediolateral and
caudocranial position.
6
5. Temporary Pin Placement:
Plate position can be temporarily fixed using the
Fixation Pin and Bone Screw Driver. The Temporary Pin
can be inserted through any of the screw holes in the
Plate and provides stability during Screw placement
(Figure 5).
6. Preparing Screw Hole:
In preparing the screw hole, the Awl may be used to
create a pilot hole. The Awl is placed in the desired
screw hole position with up to 14˚ of angulation. Press
and rotate the Awl through the Plate and into the bone
until the depth has bottomed out against the Plate. The
Awl will provide a pilot hole up to a depth of 10mm
(Figure 6). If preferred, the Drill Guide (fixed or variable
depending on Screw choice) and Drill can be used to
create the screw hole. Attach the Drill Guide to the
Plate and drill the screw hole (Fixed Drill Guide if Fixed
Screws are desired or Variable Drill Guide if Variable
Screws are desired). The Drills are provided in 12, 14,
and 16mm lengths with corresponding Drill Guides in
both variable and fixed positions (Figures 7 and 7a).
Figure 5
Figure 6
Figure 7
Figure 7a
7
SURGICAL TECHNIQUE
7. Screw Insertion:
The self-tapping, self-drilling Bone Screws are
available in 12, 14, 16, and 18mm lengths in both
4 and 4.5mm diameters. All length and diameter Bone
Screw options are available in a fixed and variable
head design. Bone Screw lengths measure from under
screw head to point. The Bone Screws selected for
implantation are inserted using the ACP Bone Screw
Driver (Figure 8). Insert the Bone Screw into the
vertebrae to be instrumented until it rests firmly inside
the plate screw hole (Figure 9). This will enable the
Locking Mechanism to be engaged. Repeat the Screw
insertion procedure for each screw hole position
within the Plate.
Figure 8
8. Locking Mechanism:
Once the Bone Screws have been properly seated,
positioned, and tightened, the Locking Mechanism can
be rotated to secure the seated Bone Screws within the
construct. Insert the ACP Locking Tool between the two
green rivets and rotate 360˚ until the rivets cover both
screw heads (Figure 10). Do not rotate rivets more than
two times as this will weaken the Locking Mechanism.
Secure all Bone Screws with the Locking Mechanism
(Figure 11). If desired the ACP Lock/Unlock tool can
be used to lock the green rivets individually. Turn the
rivet until it is fully engaged as pictured in Figure 11.
Figure 9
Figure 10
Figure 11
8
9. Closure:
After visual and radiographic confirmation of Plate,
Screw, and bone graft placement, the closure process
can proceed.
The Slimplicity Anterior Cervical Plate System surgical
technique is a general guide for instrumentation. The
surgeon should be familiar with anterior cervical fusion.
®
10. Screw Removal:
Figure 12
If needed, the Bone Screws can be removed using the
Lock/Unlock Tool. The Locking Mechanism is rotated
back to its unlocked position (Figure 12). Once the
rivet has been rotated the Screws can be removed
from the construct.
9
SLIMPLICITY IMPLANTS
®
10
Item No.
Description
ACP120
ACP122
ACP124
ACP126
ACP128
ACP130
ACP132
ACP134
ACP235
ACP237
ACP240
ACP243
ACP246
ACP249
ACP252
ACP255
ACP354
ACP357
ACP360
ACP363
ACP366
ACP369
ACP372
ACP375
ACP469
ACP473
ACP477
ACP481
ACP485
ACP489
SDF4012
SDF4014
SDF4016
SDF4018
SDF4512
SDF4514
SDF4516
SDF4518
SDV4012
SDV4014
SDV4016
SDV4018
SDV4512
SDV4514
SDV4516
SDV4518
Anterior Cervical Plate, 1-Level, 20mm
Anterior Cervical Plate, 1-Level, 22mm
Anterior Cervical Plate, 1-Level, 24mm
Anterior Cervical Plate, 1-Level, 26mm
Anterior Cervical Plate, 1-Level, 28mm
Anterior Cervical Plate, 1-Level, 30mm
Anterior Cervical Plate, 1-Level, 32mm
Anterior Cervical Plate, 1-Level, 34mm
Anterior Cervical Plate, 2-Level, 35mm
Anterior Cervical Plate, 2-Level, 37mm
Anterior Cervical Plate, 2-Level, 40mm
Anterior Cervical Plate, 2-Level, 43mm
Anterior Cervical Plate, 2-Level, 46mm
Anterior Cervical Plate, 2-Level, 49mm
Anterior Cervical Plate, 2-Level, 52mm
Anterior Cervical Plate, 2-Level, 55mm
Anterior Cervical Plate, 3-Level, 54mm
Anterior Cervical Plate, 3-Level, 57mm
Anterior Cervical Plate, 3-Level, 60mm
Anterior Cervical Plate, 3-Level, 63mm
Anterior Cervical Plate, 3-Level, 66mm
Anterior Cervical Plate, 3-Level, 69mm
Anterior Cervical Plate, 3-Level ,72mm
Anterior Cervical Plate, 3-Level, 75mm
Anterior Cervical Plate, 4-Level, 69mm
Anterior Cervical Plate, 4-Level, 73mm
Anterior Cervical Plate, 4-Level, 77mm
Anterior Cervical Plate, 4-Level, 81mm
Anterior Cervical Plate, 4-Level, 85mm
Anterior Cervical Plate, 4-Level, 89mm
4.0mm x 12mm SD Fixed Screw
4.0mm x 14mm SD Fixed Screw
4.0mm x 16mm SD Fixed Screw
4.0mm x 18mm SD Fixed Screw
4.5mm x 12mm SD Fixed Screw
4.5mm x 14mm SD Fixed Screw
4.5mm x 16mm SD Fixed Screw
4.5mm x 18mm SD Fixed Screw
4.0mm x 12mm SD Variable Screw
4.0mm x 14mm SD Variable Screw
4.0mm x 16mm SD Variable Screw
4.0mm x 18mm SD Variable Screw
4.5mm x 12mm SD Variable Screw
4.5mm x 14mm SD Variable Screw
4.5mm x 16mm SD Variable Screw
4.5mm x 18mm SD Variable Screw
SLIMPLICITY INSTRUMENTS
®
Item No.
Description
ACP-003
ACP-006
ACP-009
ACP-005F
ACP-005V
04-9024
ACP-012
ACP-014
ACP-016
00-9027
00-9021
00-9023
ACP Plate Bender
ACP Bone Awl
ACP Fixation Pin
ACP Fixed Drill Guide
ACP Variable Drill Guide
ACP Drill Universal Straight Handle
ACP Drill – 12mm
ACP Drill – 14mm
ACP Drill – 16mm
ACP 2.5mm Tapered Hex Driver
ACP Locking Tool
ACP Lock/Unlock Tool
NOTES
12
Precision Spine, Inc.
2050 Executive Drive
Pearl, MS 39208
Customer Service: 1.888.241.4773
Phone: 601.420.4244
Toll Free: 877.780.4370
Fax: 601.420.5501
www.precisionspineinc.com
Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.
Precision Spine and Slimplicity are trademarks of Precision Spine, Inc.
4052 Copyright ©2014 Precision Spine, Inc. All rights reserved. Printed in USA. xM
P/N LBL-STG-005 Rev. A 05/2014