CHESAPEAKE ® Anterior-Lumbar Stabilization System

Surgical Technique
The CHESAPEAKE Spinal System is intended to be used with the bone screws provided and
requires no additional supplementary fixation. The CHESAPEAKE implants are intended for
spinal fusion procedures using bone grafting material (autograft only) in skeletally mature

chesapeake
patients who have had six months of non-operative treatment.

When used as intervertebral body fusion devices, the implants are indicated for use at either
one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of
degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back
pain of discogenic origin with degeneration of the disc confirmed by history and radiographic
studies.

When used as vertebral body replacement devices the CHESAPEAKE implants are indicated for
use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of
a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in
order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the
height of a collapsed vertebral body. The CHESAPEAKE implants are designed to restore the
biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence
K2M, Inc. of fusion for a prolonged period.
751 Miller Drive SE
Leesburg, Virginia 20175
USA
Anterior-Lumbar Stabilization System
PH 866.K2M.4171 (866.526.4171)
FX 866.862.4144

Emergo Europe As Described By:

Molenstraat 15
2513 BH, The Hague
The Netherlands
John P. Kostuik, MD
PH +31.70.345.8570 Professor Emeritus Orthopaedics & Neurosurgery,
FX +31.70.346.7299 Johns Hopkins University
The K2M Board of Scientific Advisors &
CHESAPEAKE® Silo Members

www.K2M.com
©2011 K2M, Inc. All rights reserved.
K2-20-7003-01 Rev. 0
Licensed from Prof. Dr. D. Wolter
U.S. Patent 6,322,562
 Surgical Technique CHESAPEAKE® Anterior-Lumbar Stabilization System

Dear Colleagues,
Welcome to K2M, Inc. and the CHESAPEAKE® Anterior-Lumbar Stabilization System. Your feedback has helped
TABLE OF CONTENTS Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
communicate the needs of your surgeons and, ultimately, the development of this system.
Features & Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
CHESAPEAKE is named after one of the largest estuaries in the world, encompassing over 64,000 square miles along the
SURGICAL TECHNIQUE STEPS Eastern Shore of North America. This unique mixture of freshwater and saltwater promotes an incredibly complex ecosystem
with countless species depending on this delicate balance. Similar to the Chesapeake Bay, the CHESAPEAKE Anterior-
STEP 1: Planning, Approach, & Patient Positioning . . . . . . . 4
Lumbar Stabilization System is known for its unique balance of features.
STEP 2: Discectomy & Endplate Preparation ..........5
This multi-screw construct provides stability to the anterior column, while reducing the need for supplemental fixation in the
STEP 3: Disc Elevation . . . . . . . . . . . . . . . . . . . . . . . . . . 6
lumbar spine. Featuring the revolutionary tifix® Locking Technology, which requires no additional locking mechanism, this
STEP 4: Determining Interbody Size ................7 system exemplifies advances in innovative instrumentation and the technology required to achieve fusion.
STEP 5: Interbody Selection ......................8 Designed through an innovative, collaborative approach involving spinal surgery opinion leaders, experienced biomechanical
STEP 6: Interbody Insertion . . . . . . . . . . . . . . . . . . . . . . 10 engineers, independent testing laboratories, and the K2M product development team, the CHESAPEAKE Anterior-Lumbar
STEP 7: Drill Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Stabilization System was created to provide surgeons with a superior Anterior-Lumbar Interbody Fusion System.
STEP 8: Create Pilot Hole & Drill Vertebral Body . . . . . . . . 16 Should you have any questions, please feel free to contact us at 703.777.3155.
STEP 9: Screw Preparation & Insertion . . . . . . . . . . . . . 17 Thank you for your continued support and dedication to K2M.
STEP 10: Final Locking . . . . . . . . . . . . . . . . . . . . . . . . . 18

PRODUCT CATALOG y,
Sincerely,
K2M Anterior-Lumbar Preparation Instruments . . . . . . . . 22
CHESAPEAKE® Anterior-Lumbar Instruments . . . . . . . . . 29
CHESAPEAKE® Anterior-Lumbar Implants . . . . . . . . . . . 31 JJohn
h P.
P Kostuik,
K t ik MD
Co-Founder, Past Chairman, & Chief Medical Officer – K2M, Inc.
CHESAPEAKE® Product Insert . . . . . . . . . . . . . . . . . . . . 32 Professor Emeritus – Johns Hopkins University, Orthopaedics & Neurosurgery
Past President – Scoliosis Research Society (SRS) & North American Spine Society (NASS)

CHESAPEAKE SILO MEMBERS

Amiell Bethel,
h l MD Judson Cook, MD Ira Fedder, MD Bimal Rami, MD Charles Theofilos, MD John Williams, MD

BOARD OF SCIENTIFIC ADVISORS

Jean-Jacques Abitbol, MD Behrooz Akbarnia, MD Laurel Blakemore, MD Oheneba Boachie-Adjei, MD John Carbone, MD

Allen Carl, MD Patrick Connolly, MD Gordon Donald, MD Matthew Gornet, MD Richard Guyer, MD

George Miz, MD Mr M H Hilali Noordeen, FRCS Pierce Nunley,

eyy MD
Nunley M John Peloza, MD Faheem Sandhu, MD

Gil Tepp
Te
Tepper,
epp
pp MD
pper, Charles
arles Theofi
The
heofi
he o los, MD
M John Williams, MD
 Surgical Technique
FEATURES & BENEFITS
CHESAPEAKE® Anterior-Lumbar
Stabilization System
2 3
CHESAPEAKE® Anterior-Lumbar Stabilization System
IMPLANTS
– Featuring revolutionary tifix® Locking Technology,
which requires no additional locking mechanism
– 24 x 30 mm and 28 x 36 mm footprint available
to accommodate patients’ various anatomies
– 5°, 10°, and 15° lordotic options
– Anterior fixation with zero profile design
– A multi-screw construct with 14° converging angles
– Manufactured from Biocompatible PEEK Polymer
– Color-coded screws by length for ease of
identification intraoperatively
INSTRUMENTS
– Awls, Taps, Drills, and Drivers: Available in fixed
or universal joint options to aid in initial screw
preparation
– Single Barrel and Three Barrel Drill Guides
– Anterior Insertion Ramp: Unique insertion tool
allowing for parallel distraction and controlled
threaded insertion of the implant
– Rongeurs, Rasps, Osteotomes, and Cobbs:
Available for the preparation and decortication of
the cartilaginous endplates
– Variety of Curette Options: Facilitate the removal
of the disc, nucleus pulposus, and cartilaginous
endplate
 STEP Surgical Technique Steps
1 #4 FORWARD ANGLED CURETTE
Cranial
4 Caudal
PLANNING, APPROACH, PRE-SURGICAL PLANNING
& PATIENT POSITIONING defines the type of construct, the
most appropriate implants, and
the optimal implant location. The
CHESAPEAKE Anterior-Lumbar set is
designed to facilitate anterior surgical
approaches.
CHESAPEAKE® Anterior-Lumbar Stabilization System
CURETTE CONNECTOR SHAFT
CURETTE HANDLE
DISCECTOMY &
ENDPLATE PREPARATION
4 mm ANTERIOR PITUITARY RONGEUR 45°
2
8 mm DOUBLE ACTION RONGEUR CHISEL
CONVEX RASP SMALL COBB
5
A SELECTION OF disc preparation NOTE: For a complete listing
instruments is available to facilitate of instrument options, please
a complete discectomy and to see the Product Catalog.
decorticate the vertebral endplates.
These instruments include a variety of
cup style Curettes, Pituitary Rongeurs,
Rasps, Chisels, and Cobbs.
 STEP Surgical Technique Steps CHESAPEAKE® Anterior-Lumbar Stabilization System

3 DISC SPREADER FIXED T-HANDLE 24 x 30 mm 5° TRIAL TRIAL INSERTER

4

6 7
DISC ELEVATION A DISC SPREADER may be inserted as A starter size of 5 mm is available DETERMINING TRIALS ARE AVAILABLE in 5°, 10°, and Trials are 0.5 mm undersized to allow
a temporary spacer while additional for initial distraction. Sizes increase INTERBODY SIZE 15° of lordosis to aid in initial test fitting for a slight press fit of the implant. If the
preparation is performed on the sequentially thereafter beginning with and size confirmation of the interbody. trial appears to be too small, gradually
contralateral side. Modular Disc 7 mm to 19 mm in 2 mm increments. Load the trial onto the distal end of the increase the size until a secure fit is
Spreaders, which connect to a Fixed Distraction is performed until the Trial Inserter. The thumbwheel, located achieved.
T-Handle, are included in the set. appropriate height is achieved. on the proximal end of the Trial Inserter,
is turned in a clockwise direction to
secure the trial.
 STEP Surgical Technique Steps CHESAPEAKE® Anterior-Lumbar Stabilization System

5 24 x 30 mm
6

5° 10° 15°

24 x 30 mm

28 x 36 mm

5° 10° 15°

28 x 36 mm

8 9
INTERBODY SELECTION AN APPROPRIATELY SIZED interbody is are sized at 24 x 30 mm and 28 x 36 Each footprint includes a color-coded The interbodies are included in color-
chosen at the discretion of the surgeon; mm footprints and are available in 5°, tifix insert to easily indentify the coded caddies for ease of height
one which is securely seated with a 10°, and 15° lordotic angles in heights degrees of lordosis. The height of the identification. The implant is indicated
tight fit between the endplates when ranging from 11 mm to 19 mm in 2 interbody is measured from tip-of-tooth for spinal fusion procedures to be
the segment is fully distracted. Implants mm increments. to tip-of-tooth. used with autogenous bone graft in
skeletally mature patients.
 STEP Surgical Technique Steps CHESAPEAKE® Anterior-Lumbar Stabilization System

6
CHESAPEAKE Modular Tip

Anterior Insertion Ramp

10 11
INTERBODY INSERTION THE ANTERIOR INSERTION RAMP 1. Hold the instrument vertically to 4. Turn the shorter of the two knurled 7. Adjust the countersink depth on 9. Place the distal end of the
utilizes a controlled threaded allow the distraction ramps to thumbwheels clockwise and finger Anterior Insertion Ramp from distraction ramps into the disc

Insertion Option 1: mechanism which provides parallel open. tighten until the threads disappear 0 – 6 mm by rotating the larger space until the vertebral body
distraction, resulting in a zero-impact and components mate flush. knurled thumbwheel behind the stops make contact with the
Anterior Insertion Ramp 2. Insert the inner shaft through
load on the implant. the proximal end of the inserter 5. Attach the implant to the countersink depth bar on the anterior portion of the vertebrae.

and rotate clockwise 1-2 turns to CHESAPEAKE Modular Tip. modular tip. 10. Turn the t-handle clockwise to
To ensure proper use of the Anterior
Insertion Ramp, complete the following engage the threads. 6. Final tighten the implant by turning 8. Rotate the Anterior Insertion advance the implant into the disc
steps. 3. Place the CHESAPEAKE Modular the knob of the inner shaft on the Ramp 180-degrees to close the space.

Tip over the inner shaft. proximal end of the inserter. distraction ramps.
 STEP Surgical Technique Steps CHESAPEAKE® Anterior-Lumbar Stabilization System

6 CHESAPEAKE IMPLANT INSERTER

CHESAPEAKE IMPLANT INSERTER - INNER SHAFT

12
INTERBODY INSERTION 11. When the countersink depth bar
makes contact with the vertebral
bodies, the Anterior Insertion Ramp
Insertion Option 1:
will begin to remove itself from the
Anterior Insertion Ramp
disc space while maintaining the
(CONT.)
position of the implant according
to the pre-set countersink depth.
Continue to thread the inner shaft
until the distraction ramp is fully
removed from the disc space.
12. Disengage the implant by turning
the inner shaft knob on the proximal
end of the inserter counterclockwise.
13. Completely remove the inner
shaft for cleaning once insertion is
complete.
INTERBODY INSERTION 2. Load the interbody onto the
CHESAPEAKE Implant Inserter.
Insertion Option 2:
3. Turn the inner shaft thumbwheel
CHESAPEAKE Implant on the proximal end of the implant
Inserter
inserter in a clockwise direction to
secure the implant. The Large Mallet
1. Insert the inner shaft through the may be used to aid in implant
proximal end of the inserter and placement. X-ray or fluoroscopy may
rotate clockwise 1-2 turns to engage be used live or periodically to verify
the threads. placement.
13
4. After the implant is properly seated
in the disc space, turn the inner
shaft knob at the proximal end of
the inserter counterclockwise to
disengage the implant.
Care must be taken to protect the
vascular elements before removing the
CHESAPEAKE Implant Inserter from the
surgical site. If needed, the Removal
Tool may be used to adjust the implant
anteriorly.
 STEP Surgical Technique Steps CHESAPEAKE® Anterior-Lumbar Stabilization System

7 SINGLE BARREL DRILL GUIDE

DRILL GUIDE INSERTER

11 mm 13 mm 15 mm 17 mm 19 mm
DRILL GUIDE INSERTER

SINGLE BARREL DRILL GUIDE

EXPANDABLE DRILL GUIDE

14
DRILL GUIDES TTWO DRILL GUIDES are available for
use: A Single Barrel Drill Guide and a
Three Barrel Drill Guide. The Single
Barrel Drill Guide is used to Awl and
Drill at a fixed trajectory of 35°. The
Three Barrel Drill Guide is used to Awl,
Tap, Drill, and insert screws at a fixed
trajectory of 40°. Three Barrel Drill
Guides are available in sequential
heights from 11 mm to 19 mm in 2 mm
increments.
The Three Barrel Drill Guides
correspond to each interbody height.
Load the Three Barrel Drill Guide
onto the distal end of the Drill Guide
Inserter by pulling back on the outer shaft
of the Drill Guide Inserter to secure.
15
Insert the instrument into the interbody
making sure to match up the markings
for correct screw orientation. Turn the
green silicone handle clockwise to
secure the Three Barrel Drill Guide to
the interbody.
 STEP Surgical Technique Steps CHESAPEAKE®CHESAPEAKE
Anterior-Lumbar
®
Anterior-Lumbar
Stabilization System
Stabilization System
STEP

8 20 mm SPRING LOADED PUNCH AWL

9
20 mm AWL 20 mm UNIVERSAL AWL 20 mm TAPERED DRIVER

CHESAPEAKE
CHESAPE RATCHETING
20 mm DRILL 20 mm UNIVERSAL DRILL 20 mm UNIVERSAL TAPERED DRIVER HUDSON
HUDS HANDLE

KE RATCHETIN
CHESAPEAKE RATCHETING
HUDSON HANDLE
DLE 20 mm TAP 20 mm UNIVERSAL TAP

20 mm 25 mm 30 mm

16
16
CREATE PILOT HOLE & IF PREFERRED, THE 20 mm Spring
DRILL VERTEBRAL BODY Loaded Punch Awl, 20 mm Universal
Awl, or 20 mm Awl may be used to
perforate the vertebral body.
NOTE: The Spring Loaded Punch Awl
does not Awl through the Single Barrel
or Three Barrel Drill Guides.
Select the Ø3.0 mm x 20 mm Drill
and attach it to the Ratcheting Hudson
Handle. These drills will restrict the
depth to 20 mm through the Drill
Guides. If a power drill is required,
the Hudson Adapter may be used to
connect the drill bit to power.
SCREW PREPARATION &
INSERTION
THE CHESAPEAKE SCREWS are
color-coded by length. The screws are
self-tapping; however, the 20 mm Tap or
20 mm Universal Tap may be inserted
through the Drill Guides concentric to the
pilot hole at the same angulation it was
drilled to tap the vertebral bodies.
17
Once the appropriately sized screw is If preferred, the Size 20 Universal Driver
selected, insert it through the implant may be used when it is necessary to
using the Size 20 Tapered Driver insert the screw off axis.
attached to the Ratcheting Hudson
Handle and preliminarily tighten the
screw. The Driver has a tapered, self
NOTE: Repeat Steps 8 and 9 for the
holding tip to provide for easy insertion
remaining screws.
of the screws.
 STEP Surgical Technique Steps CHESAPEAKE® Anterior-Lumbar Stabilization System

10 CHESAPEAKE TORQUE WRENCH – 20 IN.-LBS

SIZE 20 NON-TAPERED DRIVER 14

18
FINAL LOCKING
FINAL SCREW LOCKING should only
be performed once the screw positions
have been verified via intraoperative
radiographs. Once the screws are
tightened, they will become locked to
the tifix insert.
Use the Size 20 Non-Tapered Driver
attached to the Gray Torque Limiting
Handle to final tighten the screws to 20
in-lbs.
When the screw head engages on the
locking lip of the tifix insert, the insert
will lag down to the bone and the
revolutionary tifix Locking Technology
will commence. Due to a difference
in material hardness and design, the
screw head begins to deform the tifix
insert through a reshaping process and
thus forms an autogenic lock.
The Toque Limiting Handle emits an
audible “click” at 20 in-lbs to signify
the screw has formed an autogenic
lock with the tifix insert. Use of the
Torque Limiting Handle further ensures
that the screw in not over tightened.
No additional locking step is required.
19
NOTE: Optionally, if realignment
of the screw is required after final
tightening, the screw may be unlocked
using the Ratcheting Hudson Handle
and the Size 20 Tapered Driver. The
screw may be locked and unlocked up
to three times without compromising the
locking mechanism.
 Notes CHESAPEAKE® Anterior-Lumbar Stabilization System

CHESAPEAKE
PRODUCT CATALOG
20 21
 Product Catalog CHESAPEAKE® Anterior-Lumbar Stabilization System
TRIALS INSTRUMENTS

#2 STRAIGHT CURETTE
K2M ANTERIOR-LUMBAR PREPARATION

#4 STRAIGHT CURETTE

#2 FORWARD ANGLED CURETTE

24 x 30 mm 5°, 10°, & 15° TRIALS
Heights (mm): 9, 11, 13, 15, 17, 19 #4 FORWARD ANGLED CURETTE

#2 SERRATED CURETTE

#4 SERRATED CURETTE

28 x 36 mm 5°, 10°, & 15° TRIALS

#2 30° FORWARD CURETTE
Heights (mm): 9, 11, 13, 15, 17, 19

#4 30° FORWARD CURETTE

CURETTE CONNECTOR SHAFT

CURETTE HANDLE

* 9 mm Trials are for use with the ALEUTIAN® Anterior-Lumbar Interbody System

22 23

TRIALS TRIALS INSTRUMENTS

DESCRIPTION CATALOG NUMBER DESCRIPTION CATALOG NUMBER DESCRIPTION CATALOG NUMBER DESCRIPTION CATALOG NUMBER
9 mm 24 x 30 mm 5° Trial 702-90070 11 mm 24 x 30 mm 15° Trial 702-90170 9 mm 28 x 36 mm 10° Trial 702-90113 #2 Straight Curette 702-90001
11 mm 24 x 30 mm 5° Trial 702-90071 13 mm 24 x 30 mm 15° Trial 702-90171 11 mm 28 x 36 mm 10° Trial 702-90114 #4 Straight Curette 702-90002
13 mm 24 x 30 mm 5° Trial 702-90072 15 mm 24 x 30 mm 15° Trial 702-90172 13 mm 28 x 36 mm 10° Trial 702-90115 #2 Forward Angled Curette 702-90162
15 mm 24 x 30 mm 5° Trial 702-90073 17 mm 24 x 30 mm 15° Trial 702-90173 15 mm 28 x 36 mm 10° Trial 702-90116 #4 Forward Angled Curette 702-90003
17 mm 24 x 30 mm 5° Trial 702-90074 19 mm 24 x 30 mm 15° Trial 702-90174 17 mm 28 x 36 mm 10° Trial 702-90117 #2 Serrated Curette 702-90163
19 mm 24 x 30 mm 5° Trial 702-90075 9 mm 28 x 36 mm 5° Trial 702-90084 19 mm 28 x 36 mm 10° Trial 702-90118 #4 Serrated Curette 702-90164
9 mm 24 x 30 mm 10° Trial 702-90106 11 mm 28 x 36 mm 5° Trial 702-90085 9 mm 28 x 36 mm 15° Trial 702-90084 #2 30° Forward Curette 702-90165
11 mm 24 x 30 mm 10° Trial 702-90107 13 mm 28 x 36 mm 5° Trial 702-90086 11 mm 28 x 36 mm 15° Trial 702-90175 #4 30° Forward Curette 702-90166
13 mm 24 x 30 mm 10° Trial 702-90108 15 mm 28 x 36 mm 5° Trial 702-90087 13 mm 28 x 36 mm 15° Trial 702-90176 Curette Connector Shaft 602-90010
15 mm 24 x 30 mm 10° Trial 702-90109 17 mm 28 x 36 mm 5° Trial 702-90088 15 mm 28 x 36 mm 15° Trial 702-90177 Curette Handle 702-90210
17 mm 24 x 30 mm 10° Trial 702-90110 19 mm 28 x 36 mm 5° Trial 702-90089 17 mm 28 x 36 mm 15° Trial 702-90178
19 mm 24 x 30 mm 10° Trial 702-90111 19 mm 28 x 36 mm 15° Trial 702-90179
 Product Catalog CHESAPEAKE® Anterior-Lumbar Stabilization System
INSTRUMENTS INSTRUMENTS

5 mm DISC SPREADER LARGE COBB

7 mm DISC SPREADER SMALL COBB

9 mm DISC SPREADER 15 mm CHISEL

17 mm CHISEL
11 mm DISC SPREADER

13 mm DISC SPREADER PUSHER

15 mm DISC SPREADER 13” 4 mm & 6 mm ANTERIOR

PITUITARY RONGEUR 45°
17 mm DISC SPREADER
13” 4 mm & 6 mm ANTERIOR
PITUITARY RONGEUR
19 mm DISC SPREADER WITH TEETH

8 mm DOUBLE ACTION
FIXED T-HANDLE WITH RONGEUR
HUDSON

LARGE SCALPEL BLADE HOLDER

SMALL SCALPEL BLADE HOLDER

24 25

INSTRUMENTS INSTRUMENTS

DESCRIPTION CATALOG NUMBER DESCRIPTION CATALOG NUMBER DESCRIPTION CATALOG NUMBER

5 mm Disc Spreader 702-90058 Large Cobb 702-90068 13” 4 mm Anterior Pituitary

Rongeur with Teeth 702-90099
7 mm Disc Spreader 702-90059 Small Cobb 702-90067
13” 6 mm Anterior Pituitary
9 mm Disc Spreader 702-90060 15 mm Chisel 702-90158
Rongeur with Teeth 702-90100
11 mm Disc Spreader 702-90061 17 mm Chisel 702-90159
8 mm Double Action Rongeur 702-90101
13 mm Disc Spreader 702-90062 Pusher 702-90208
Large Scalpel Blade Holder 702-90066
15 mm Disc Spreader 702-90063 13” 4 mm Anterior Pituitary
Small Scalpel Blade Holder 702-90182
Rongeur 45° 702-90098
17 mm Disc Spreader 702-90064
13” 6 mm Anterior Pituitary
19 mm Disc Spreader 702-90065
Rongeur 45° 702-90157
Fixed T-Handle with Hudson 602-90225
 Product Catalog CHESAPEAKE® Anterior-Lumbar Stabilization System
INSTRUMENTS
INSTRUMENTS

MODULAR ANTERIOR
INSERTION RAMP 20 mm TAP

INNER SHAFT ASSEMBLY 20 mm UNIVERSAL TAP

CHESAPEAKE MODULAR TIP -

ZERO COUNTERSINK
20 mm AWL

ANGLED RASP

20 mm UNIVERSAL AWL
CONVEX RASP

TRIAL INSERTER 20 mm SPRING-LOADED PUNCH AWL

LARGE MALLET

20 mm DRILL

SLAP HAMMER

26 27

INSTRUMENTS INSTRUMENTS

DESCRIPTION CATALOG NUMBER DESCRIPTION CATALOG NUMBER

Modular Anterior Insertion Ramp 2008-90018 20 mm Tap 2008-90040

Inner Shaft Assembly 2008-90019 20 mm Universal Tap 2008-90054
CHESAPEAKE Modular Tip - Zero Countersink 2008-90055 20 mm Awl 2008-90028
Angled Rasp 702-90103 20 mm Universal Awl 2008-90025
Convex Rasp 702-90183 20 mm Spring-Loaded Punch Awl 2008-90046
Trial Inserter 702-90167 20 mm Drill 2008-90029
Large Mallet 702-90052
Slap Hammer 702-90181
 Product Catalog CHESAPEAKE® Anterior-Lumbar Stabilization System

INSTRUMENTS INSTRUMENTS

20 mm UNIVERSAL DRILL SINGLE BARREL DRILL GUIDE

EXPANDABLE DRILL GUIDE - 11 mm

SIZE 20 TAPERED DRIVER

EXPANDABLE DRILL GUIDE - 13 mm

SIZE 20 NON-TAPERED DRIVER

SIZE 20 UNIVERSAL EXPANDABLE DRILL GUIDE - 15 mm

TAPERED DRIVER

EXPANDABLE DRILL GUIDE - 17 mm

RATCHETING HUDSON HANDLE

EXPANDABLE DRILL GUIDE - 19 mm

TORQUE WRENCH – 20 IN-LBS

DRILL GUIDE INSERTER

28 29

INSTRUMENTS INSTRUMENTS
NTS

DESCRIPTION CATALOG NUMBER DESCRIPTION CATALOG NUMBER

20 mm Universal Drill 2008-90051 Single Barrel Drill Guide 2008-90039

Size 20 Tapered Driver 2008-90030 Expandable Drill Guide - 11 mm 2008-90058
Size 20 Non-Tapered Driver 2008-90044 Expandable Drill Guide - 13 mm 2008-90059
Size 20 Universal Tapered Driver 2008-90024 Expandable Drill Guide - 15 mm 2008-90060
Ratcheting Hudson Handle 2008-90042 Expandable Drill Guide - 17 mm 2008-90061
Torque Wrench – 20 in-lbs 2008-90043 Expandable Drill Guide - 19 mm 2008-90062
Drill Guide Inserter 2008-90037
 Product Catalog CHESAPEAKE® Anterior-Lumbar Stabilization System

IN
INSTRUMENTS IMPLANTS

CHESAPEAKE IMPLANT
INSERTER
24 x 30 mm 5°, 10°, & 15°
Heights (mm): 11, 13, 15, 17, 19
CHESAPEAKE IMPLANT
INSERTER – INNER SHAFT

REMOVAL TOOL

28 x 36 mm 5°, 10°, & 15°

Heights (mm): 11, 13, 15, 17, 19

Ø5.5 mm SCREWS
Lengths (mm) 20, 25, 30

30 31

INSTRUMENTS

DESCRIPTION CATALOG NUMBER

CHESAPEAKE Implant Inserter 2008-90063

CHESAPEAKE Implant Inserter – Inner Shaft 2008-90065
Removal Tool 2008-90068
 Product Insert
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION
IMPORTANT
This booklet is designed to assist in using the CHESAPEAKE® Spinal
System. It is not a reference for surgical techniques.
CAUTION: Federal law (USA) restricts this device to sale
and use by, or on the order of, a physician.
INDICATIONS
The CHESAPEAKE Spinal System is intended to be used with the bone
screws provided and requires no additional supplementary fixation.
The CHESAPEAKE implants are intended for spinal fusion procedures
using bone grafting material (autograft only) in skeletally mature
patients who have had six months of non-operative treatment.
When used as intervertebral body fusion devices, the implants are
indicated for use at either one level or two contiguous levels in the
lumbar spine, from L2 to S1, for the treatment of degenerative disc
disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined
as back pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies.
When used as vertebral body replacement devices the CHESAPEAKE
implants are indicated for use in the thoracolumbar spine (T1 to L5)
for partial replacement (i.e., partial vertebrectomy) of a diseased
vertebral body, resected or excised for the treatment of tumors or
trauma/fracture in order to achieve anterior decompression of the
spinal cord and neural tissues, and to restore the height of a collapsed
vertebral body. The CHESAPEAKE implants are designed to restore
the biomechanical integrity of the anterior, middle, and posterior
spinal column even in the absence of fusion for a prolonged period.
MATERIALS
The implants of the CHESAPEAKE Spinal System are manufactured
from PEEK-OPTIMA® Polymer Polyetheretherketone, Tantalum,
Ti6Al4V and CP Titanium, per ISO and ASTM standards.
CLEANING/REPROCESSING OF K2M SURGICAL INSTRUMENTS
K2M surgical instruments are supplied non-sterile. While it
is recommended that the following steps are included in a
decontamination/ reprocessing protocol the end-user bears the
ultimate responsibility for the cleanliness of the device. These
instructions are not intended for K2M implants or disposable surgical
instruments.
32 Presoak the instruments with an enzymatic solution for a minimum
of 5 minutes. Following the presoak the instruments should be wiped
or scrubbed using a brush, cloth or sponge that does not mar the
surface of the instrument. Remove soil from cannulated parts with
a nylon bristle brush or appropriately sized guide wire. Rinse parts
under water for one minute. Repeat the process until no visible debris
remains. Clean K2M surgical instruments with an appropriate brush,
cloth or sponge and low foaming, pH neutral detergent solution. The
use of abrasive compounds or excessively acidic or alkaline solutions
may cause damage to the instruments and should be avoided. Rinse
parts under warm or hot flowing water for a minimum of 1 minute
including direct contact with all surfaces for at least 10 seconds.
Repeat rinsing step using distilled, reverse osmosis or deionized water.
Automatic cleaning may be used in addition to manual cleaning. Do
not ultrasonically clean torque limiting handles.
STERILIZATION
Unless specifically labeled sterile, the implants and instruments
are supplied NONSTERILE and MUST be sterilized prior to use.
Recommended sterilization methods include steam autoclaving after
removal of all protective packaging and labeling. The following steam
autoclave cycles are recommended, however sterilization should be
in accordance with the sterilizer manufacturer’s instructions and the
institution’s procedures for assuring sterility.
Autoclave Cycle: Prevacuum
Temperature: 270°F (132°C)
Time: 45 minutes
Drying Time: 30 minutes
Usage of an FDA cleared wrap to ensure that the device is actually
sterile prior to implantation is recommended.
Use caution during sterilization and storage. Do not allow contact with
metal or other hard objects that could damage the finish or prevent
proper use. (See Preoperative Warnings and Precautions).
NOTE: Instruments that may have been exposed to Creutzfeldt-Jakob
disease (CJD) should be treated according to the hospital’s prion
decontamination protocol. K2M recommends contacting the Centers
for Disease Control and the World Health Organization for the most
recent information on CJD transmission and deactivation.
lNSTRUCTIONS FOR USE
(For complete instructions refer to the appropriate surgical technique
provided by your local K2M sales representative.)
The CHESAPEAKE Spinal System should only be implanted by
surgeons who are fully experienced in the use of such implants and
the required specialized spinal surgery techniques.
CONTRAINDICATIONS
1. The CHESAPEAKE Spinal System is contraindicated in the
presence of infection, pregnancy, metabolic disorders of
calcified tissues, grossly distorted anatomy, inadequate
tissue coverage, drug/ alcohol abuse, mental illness, general
neurological conditions, immunosuppressive disorders, patients
with known sensitivity to materials in the device, obesity,
patients who are unwilling to restrict activities or follow medical
advice, and any condition where the implants interfere with
anatomical structures or precludes the benefit of spinal surgery.
2. Biological factors such as smoking, use of nonsteroidal anti-
inflammatory agents, the use of anticoagulants, etc. all have a
negative effect on bony union. Contraindications may be relative
or abso-lute and must be carefully weighed against the patient’s
entire evaluation.
3. This device is not intended for use except as indicated.
POTENTIAL ADVERSE EVENTS
1. Potential adverse events include, but are not limited to
pseudoarthrosis; loosening, bending, cracking or fracture
of components, or loss of fixation in the bone with possible
neurologic damage, usually attributable to pseudoarthrosis,
insufficient bone stock, excessive activity or lifting, or one or
more of the factors listed in Contraindications, or Warnings
and Precautions; infections possibly requiring removal of
devices; palpable components, painful bursa, and/or pressure
necrosis; and allergies, and other reactions to device materials
which, although infrequent, should be considered, tested for (if
appropriate), and ruled out preoperatively.
2. Potential risks also include those associated with any spinal
surgery resulting in neurological, cardiovascular, respiratory,
gastrointestinal or reproductive compromise, or death.
CHESAPEAKE® Anterior-Lumbar Stabilization System
WARNINGS AND PRECAUTIONS
1. The CHESAPEAKE Spinal System is intended for use for the
indications listed. Safety and effectiveness of the implants have
not been established for other applications. The implants are
for single use only and are not designed to be combined with
devices from other manufacturers.
2. For optimum results careful preoperative diagnosis and planning,
meticulous surgical technique and extended postoperative care
by experienced spinal surgeons are essential. Prior to use, the
surgeon should be specifically trained in the use of this system
and the associated instrumentation to facilitate correct selection
and placement of the implants. The size and shape of bones
and soft tissue place limitations on the size and strength of the
implants and proper selection will reduce the risk of breakage or
migration of the device.
3. Patient selection and compliance is extremely important.
Spinal implant surgery on patients with conditions listed under
Contraindications may not be candidates for this procedure. The
patient must be made aware of the limitations of the implant
and that physical activity and load bearing have been implicated
in premature loosening, bending or fracture of internal fixation
devices. The patient should understand that a PEEK Polymer
implant is not as strong as a normal, healthy bone and will
fracture under normal load bearing in the absence of complete
bone healing. An active, debilitated or uncooperative patient who
cannot properly restrict activities may be at particular risk during
postoperative rehabilitation.
4. Potential risks identified with the use of this device system
which may require additional surgery include device component
failure, loss of fixation, non-union, fracture of the vertebra, and
neurological, vascular or visceral injury.
5. Cutting, bending, or scratching the surface of metal components
can significantly reduce the strength and fatigue resistance of
the implant system and should be avoided where possible. These,
in turn may cause cracks and/or internal stresses that are not
obvious to the eye and may lead to fracture of the components.
Especially avoid sharp or reverse bends and notches.
6. Special protection of implants and instruments during storage is
recommended when exposed to corrosive environments such as
moisture, salt, air, etc.
7. The CHESAPEAKE Spinal System implants are intended to
provide temporary stabilization. If an implant remains implanted
after complete healing it can actually increase the risk of
refracture in an active individual. The surgeon should weigh the
risks versus the benefits when deciding whether to remove the
implant.
8. This device has not been evaluated for safety and compatibility
in the MR environment. This device has not been tested for
heating or migration in the MR environment
PREOPERATIVE
1. Patient conditions and/or predispositions such as those
previously addressed in Contraindications and Warnings and
Precautions should be avoided.
2. Preoperative planning should identify degree of correction
possible without neurological damage using techniques similar
to other intervertebral body fusion procedures.
3. Use care in handling and storage of the implants. Prior to
surgery components should be inspected for any evidence of
damage or corrosion.
4. An adequate inventory of implant sizes should be available at
the time of the surgery.
5. All components should be cleaned and sterilized before use.
6. Before the initial experience we recommend that the surgeon
critically review all available information and consult with other
surgeons having experience with the device.
OPERATIVE
1. The primary goal of this surgery is to arthrodese selected
vertebrae. Adequate exposure, bony preparation and grafting
are essential to achieving this result.
2. The placement of the intervertebral body implants should
be checked radiographically prior to final tightening of the
construct.
3. Care should be taken when positioning the implants to avoid
neurological damage.
POSTOPERATIVE
1. Adequately instruct the patient. Postoperative care and the
patient’s ability and willingness to follow instructions are two of
the most important aspects of successful healing.
2. Internal fixation devices are load sharing devices which maintain
alignment until healing occurs. If healing is delayed or does not
occur the implant could eventually break, bend or loosen. Loads
produced by load bearing and activity levels will impact the
longevity of the implant.
3. Implants can loosen, fracture, corrode, migrate, cause pain, or
stress shield bone, even after a bone has healed. If an implant
remains implanted after complete healing, it can actually
increase the risk of refracture in an active individual. The
surgeon should weigh the risks versus benefits when deciding
33
whether to remove the implant. Implant removal should be
followed by adequate postoperative management to avoid
refracture.
4. Periodic X-rays for at least the first year postoperatively
are recommended for close comparison with postoperative
conditions to detect any evidence of changes in position,
nonunion, loosening, and bending or cracking of components.
With evidence of these conditions, patients should be closely
observed, the possibilities of further deterioration evaluated,
and the benefits of reduced activity and/or early revision
considered.
5. Surgical implants must never be reused. An explanted PEEK
implant should never be reimplanted. Even though the device
appears undamaged, it may have small imperfections and
internal stress patterns which may lead to early breakage.
 Notes CHESAPEAKE® Anterior-Lumbar Stabilization System

34 35
 Notes

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