medtronic - Compact Cornerstone

INL NO.
A8541 PROJECT Medtronic DESCRIPTION spine_compact_cornerstone_3implants_ST_updates

Compact CORNERSTONE-SR® &
Compact CORNERSTONE-SR® Alliance™
Compact CORNERSTONE-SR® Ti-Coated
ANATOMICAL CERVICAL CAGES
Surgical Technique
Not for use in the

U.S. or its territories
The Compact CORNERSTONE-SR®, Compact CORNERSTONE-SR® Alliance™ and
Compact CORNERSTONE-SR® Ti-Coated are anatomical cervical cages used to
stabilize the spine and promote bone fusion following interbody fusion surgery in
Compact CORNERSTONE-SR® &
the cervical spine. Compact CORNERSTONE-SR® Alliance™
The implants are available in a variety of widths, heights and geometries for
adaptability to patient anatomy. Compact CORNERSTONE-SR® Ti-Coated
The cages' hollow design allows for in situ packing with autograft or synthetic bone ANATOMICAL CERVICAL CAGES
substitute.
Surgical Technique
Table of Contents
Implant Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Surgical Exposre and Distraction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Neurological Dicompression and Trialing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Implant Inserter Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Bone Grafting Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Implantation and Explantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Product Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Important product Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Compact CORNERSTONE-SR® Anatomical Cervical Cage Compact CORNERSTONE-SR® Anatomical Cervical Cage
4 Surgical Technique | Compact CORNERSTONE-SR® Alliance™ Anatomical Cervical Cage Surgical Technique | Compact CORNERSTONE-SR® Alliance™ Anatomical Cervical Cage 5
Compact CORNERSTONE-SR® Ti-Coated Compact CORNERSTONE-SR® Ti-Coated
Implant Features Surgical Exposure and Distraction
COMPACT CORNERSTONE-SR® SURGICAL EXPOSURE
Surgical approach to the targeted cervical disc is carried out with a

traditional anterior fusion procedure. Standard retractors or the TRIMLINE®
Instrument Set are required in order to have a straight anterior access to
the disc.
DISTRACTION (3-STEP PROCEDURE)

Figure 1
This procedure must be followed carefully for proper insertion of the cage.
COMPACT CORNERSTONE-SR® ALLIANCE TM
• 4 Titanium Fixation Spikes

• Beveled Edge PEEK-OPTIMA®
MATERIAL: 1 DISTRACTION INSERTION
To facilitate the introduction of the distractor forceps and to maintain
distraction of the disc space, a TRIMLINE® Vertebral Body Distractor II
• Biocompatible
is recommended (Figure 1). This distractor features cannulated legs,
• Bone-like modulus
threaded pin, and nuts to allow for correction in the sagittal plane
• Designed for anatomical fit
and create maximum stability during the impaction maneuver. It is
recommended to affix the pins slightly off-center in order to have a
Radiolucency better anchor in the vertebral body.
• Facilitates visualization
of bone growth
2
• M
inimizes scatter or PREPARATION OF DISC SPACE AFTER MILD PREDISTRACTION
artifact on CT scans The anterior longitudinal ligament should be resected in a
rectangular shape. A discectomy is performed in the usual manner.
The disc material must be resected to facilitate placement of the
COMPACT CORNERSTONE-SR® TI-COATED*
distraction forceps.
• Commercially Pure Titanium Coating
- The titanium coated PEEK implant has a similar radiolucency to (uncoated) PEEK and can allow
3
for adequate intra- and post-operative imaging
PARALLEL DISC DISTRACTION (FACET JOINT RELEASE)
Insert the distraction forceps into the disc space, down to the
- The addition of the ti coating increases the surface area of the implant by approximately 550%
posterior border of the vertebral body (Figure 2). Apply progressive,
- The titanium coating creates a rough surface on the endplate contacting sides of the implant controlled distraction to get a good exposure of the epidural space.
Maintain and adjust the distraction using the TRIMLINE® Vertebral
Body Distractor II. Remove the distraction forceps.
Figure 2
Neurological Decompression and Trialing Instrument Sets
NEUROLOGICAL DECOMPRESSION IMPLANT INSERTER ASSEMBLING
The cartilage layer on the vertebral end plates is removed. Neurological Select the depth stop that matches the size of the trial from the
decompression is achieved using a Kerrison or a MIDAS REX® High Speed trialing step.
Drill.
Place the depth stop on the inserter outer shaft first and then,
For placement of the trial, it may be necessary to remove anterior insert the inserter inner shaft through them. Screw it until you
osteophytes or other anterior bone irregularities. The end plates should pass the threaded portion (Figure 4). Figure 4
remain intact.
IMPLANT TRIALING
Prior fluoroscopic control is recommended to assess disc height and

choose the appropriate anatomical trial. The trials are engraved according
to their size. Place the trial in the disc space (Figure 3) until depth stop is in
contact with anterior wall of the vertebra. Release distraction until the trial
fits firmly between the end plates.
IMPLANT ATTACHMENT
The appropriate size implant is chosen from the trialing step.
Begin by inserting the threaded hole of the cage

into the threaded tip of the inserter (Figure 5).
Press the cage in the direction of the inserter shaft.
Figure 3 Figure 5
Turn the thumb wheel to lock
the implant into position..
Bone Grafting Solutions Instrument Sets
AUTOGENOUS BONE IMPLANTATION
If autogenous bone graft is used to fill the cage, harvesting should be Using the Inserter (Figure 8), place the cage into the disc space, preferably
carried out in the usual manner. Place the cage with the inserter on a flat under fluoroscopic control, until depth stop is in contact with anterior wall
surface and pack it with bone graft or bone substitute material. (Figure 6) of the vertebra (Figure 9).
Figure 6
Figure 8
Figure 9
NANOSTIM™ SYNTHETIC BONE PASTE EXPLANTATION

(TO BE USED WITH AUTOGRAFT)
If it becomes necessary to remove the implant, apply distraction using the
NANOSTIM™ Synthetic Bone Paste is a resorbable hydroxyapatite bone cervical distractor, reconnect the inserter on the implant and retrieve with
grafting paste that uses nanotechnology to facilitate new bone formation the help of forceps or nerve hook if necessary
and bone healing (Figure 7).
If using NANOSTIM™ Synthetic Bone Paste as an autograft extender

when local bone is available, filling the cage will be performed before
implantation according to the instructions for use (IFU).
Figure 7
Product Ordering Information

Compact CORNERSTONE-SR®
IMPLANTS OPTIONAL IMPLANTS INSTRUMENT SET OPTIONAL INSTRUMENT SET
Description Description
Part Number Part Number Part Number Description Part Number Description
(Width xw Depth x Posterior Height) (Width xw Depth x Posterior Height)
6211404 14mm x 11mm x 4mm 6211407 14mm x 11mm x 7mm 6212445 14x11x4/5 Anatomical Dual End Trial 8756480 TRIMLINE® Instrument Set Distractor, Right
6211405 14mm x 11mm x 5mm 6211408 14mm x 11mm x 8mm 6212467 14x11x6/7 Anatomical Dual End Trial 8756481 TRIMLINE® Instrument Set Distractor, Left
6211406 14mm x 11mm x 6mm 6211409 14mm x 11mm x 9mm 6212489 14x11x8/9 Anatomical Dual End Trial 8756490 Distractor Pin Driver
6211604 16mm x 14mm x 4mm 6211607 16mm x 14mm x 7mm 6212645 16x14x4/5 Anatomical Dual End Trial 8756412 12mm Threaded Pin
6211605 16mm x 14mm x 5mm 6211807 18mm x 16mm x 7mm 6212667 16x14x6/7 Anatomical Dual End Trial 8756414 14mm Threaded Pin
6211606 16mm x 14mm x 6mm 6212845 18x16x4/5 Anatomical Dual End Trial 8756416 16mm Threaded Pin
6211804 18mm x 16mm x 4mm 6212867 18x16x6/7 Anatomical Dual End Trial 8756450 Nuts
6211805 18mm x 16mm x 5mm 6213010 Inserter Inner Shaft
6211806 18mm x 16mm x 6mm 6213020 Inserter Outer Shaft
6213045 4/5 Depth Stop

Compact CORNERSTONE-SR® Alliance™
IMPLANTS OPTIONAL IMPLANTS
Part Number Part Number
621001404 14mm x 11mm x 4mm 621001407 14mm x 11mm x 7mm
621001606 16mm x 14mm x 6mm
621001804 18mm x 16mm x 4mm
621001805 18mm x 16mm x 5mm
621001806 18mm x 16mm x 6mm
COMPATIBLE WITH THE 3 CAGES

Compact CORNERSTONE-SR® Ti-Coated
IMPLANTS OPTIONAL IMPLANTS
Part Number Part Number
6221606 16mm x 14mm x 6mm
6221804 18mm x 16mm x 4mm
6221805 18mm x 16mm x 5mm
6221806 18mm x 16mm x 6mm
Important Information Important Information cont

PURPOSE may limit the degree of obtainable correction and the • Cessation of growth of the fused portion of the spine. DEVICE FIXATION
The CORNERSTONE-SR® Ti-Coated Cervical Fusion System is a amount of mechanical fixation. • Discitis, arachnoiditis, and/or other types of inflammation. Installation and positional adjustment of implants must only
device intended for stabilization and to promote bone fusion • Allergy or intolerance linked to the material. • Deep venous thrombosis, thrombophlebitis, and/or be done with special ancillary instruments and equipment
during the normal healing process following surgical • Any case not needing a bone graft and fusion. pulmonary embolus. supplied and designated by Medtronic. In the interests of
correction of disorders of the cervical spine. This device • Bone graft donor site complication. patient safety, it is therefore recommended that Medtronic
• Any patient having inadequate tissue coverage over the
should be only be implanted by a physician who is fully implants are not used with devices from any other source.
operative site. • Inability to resume activities of normal daily living.
conversant with the device, intended use, instrumentation,
and with knowledge of the surgical techniques required. • Any case not described in the indications. • Death. Never under any circumstances reuse a CORNERSTONE-SR®
• Any patient unwilling to cooperate with postoperative Ti-Coated Cervical Fusion System device. Even when a
instructions. removed device appears undamaged, it may have small
DESCRIPTION WARNINGS
defects or internal stress patterns that may lead to early
These CORNERSTONE-SR® Ti-Coated Cervical Fusion System • Patients with a known hereditary or acquired bone friability A successful result is not always achieved in every surgical breakage.
devices consist of commercially pure titanium (CP Ti) coated or calcification problem should not be considered for this case. This fact is especially true in spinal surgery where other
PEEK (Polyetheretherketone) cages of various widths, heights, type of surgery. patient conditions may compromise the results. This device
and geometries which can be inserted between two cervical • Paediatric cases or where the patient still has general skeletal system is not intended to be the sole means of spinal support. PREOPERATIVE
vertebral bodies to give support and correction during growth. Use of this product without a bone graft or in cases that do • Only patients that meet the criteria described in the
interbody fusion surgeries. The hollow geometry of the not develop a union will not be successful. No spinal implant indications should be selected.
• This spinal implant system is not designed, intended, or sold
implants allows them to be packed in situ. Autogenous bone can withstand body loads without the support of bone. In this
for uses other than those indicated. • Patient conditions and/or predispositions such as those
graft or bone substitute material could be used. event, bending, loosening, disassembly and/or breakage of
• This device should be implanted only by a physician who is the device(s) will eventually occur. addressed in the aforementioned contraindications should
fully conversant with the device, intended use, be avoided.
Preoperative and operating procedures, including knowledge
THE USE OF ADDITIONAL SUPPORT INSTRUMENTATION instrumentation, and with knowledge of the surgical • Care should be used in the handling and storage of the
of surgical techniques and proper selection and placement of
MAY BE APPROPRIATE. techniques required. the implants are important considerations in the successful implant components. The implants should not be scratched
No warranties, express or implied, are made. Implied utilization of the system by the surgeon. Further, the proper or damaged. Implants and instruments should be protected
warranties of merchantability and fitness for a particular POSSIBLE ADVERSE EFFECTS selection and compliance of the patient will greatly affect the during storage especially from corrosive environments.
purpose or use are specifically excluded. results. Patients who smoke have been shown to have an
Adverse effects may occur when the device is used either • Since mechanical parts are involved, the surgeon should be
with or without associated instrumentation. The risk of increased incidence of non-unions. These patients should be
familiar with the various components before using the
INDICATIONS advised of this fact and warned of this consequence. Obese,
adverse effects as a result of movement and non-stab ilization equipment and should personally assemble the devices to
malnourished, and/or alcohol abuse patients and those with
The CORNERSTONE-SR® Ti-Coated Cervical Fusion System is may increase in cases where associated instrumentation is not verify all parts and necessary instruments are present before
poor muscle and bone quality and/or nerve paralysis are also
generally indicated for: employed. Potential adverse events include but are not surgery.
poor candidates for spine fusion. A device that has been
• degenerative discopathy and instability limited to:
implanted should never be reused, reprocessed, or resterilized • The type of construct to be assembled for the case should
- primary surgery for certain progressive degenerative • Early or late loosening or movement of the device(s). under any circumstances. Sterile packaged devices should also be determined prior to surgery. An adequate inventory of
discopathies or extensive anterior decompression • Implant migration. never be resterilized. Reuse, reprocessing, or resterilization implant sizes should be available at the time of surgery,
- revision surgery for failed disc operation, stenosis, and/or • Breakage of any or all of the components or instruments. may compromise the structural integrity of these implants including sizes larger and smaller than those expected to be
post-operative instability and create a risk of contamination of the implants which could used.
• Foreign body reaction to the implants including possible result in patient injury, illness, or death.
• pseudarthrosis or failed arthrodesis. tumor formation, auto immune disease, and/or scarring.
• Pressure on the surrounding tissues or organs, possibly INTRAOPERATIVE
PRECAUTIONS
CONTRAINDICATIONS resulting in oesophagus or trachea breakdown from • The instructions in the available CORNERSTONE-SR® Ti-
component parts where there is inadequate tissue coverage PHYSICIAN NOTE: Although the physician is the learned
Contraindications include, but are not limited to: Coated Cervical Fusion System surgical technique manual
over the implant. Implant or graft extrusion can lead to intermediary between the company and the patient, the
• Infection local to the operative site. important medical information given in this document should should be carefully followed.
fistular complications.
• Signs of local inflammation. be conveyed to the patient. • At all times, extreme caution should be used around the
• Loss of proper spinal curvature, correction, height, and/or
• Fever or leukocytosis. spinal cord and nerve roots. Damage to the nerves will cause
reduction.
• Morbid obesity. IMPLANT SELECTION loss of neurological function.
• Infection.
• Pregnancy. The selection of the proper size, shape and design of the • Breakage, slippage, or misuse of instruments or implant
• Bone fracture or stress shielding at, above, or below the level components may cause injury to the patient or operative
• Mental illness. implant for each patient is crucial to the success of the
of surgery. procedure. Surgical implants are subject to repeated stresses personnel.
• Any other medical or surgical process which would preclude • Non-union (or pseudoarthrosis). in use, and their strength is limited by the need to adapt the
the potential benefit of spinal implant surgery, such as the • To ensure fusion around the implant, autogenous bone graft
• Loss of neurological function, appearance of radiculopathy, design to the size and shape of human bones. Unless great can be used. Autogenous bone should be used for filling of
presence of tumors or congenital abnormalities, fracture local to care is taken in patient selection, proper placement of the
dural tears, and/or development of pain. the implant.
the operating site, elevation of sedimentation rate unexplained implant, and postoperative management to minimize stresses
by other diseases, elevation of white blood count (WBC), or a • Neurovascular compromise including paralysis or other types • Bone cement should not be used because this material will
on the implant, such stresses may cause material fatigue and
marked left shift in the WBC differential count. of serious injury. make removal of the components difficult or impossible. The
consequent breakage, bending, or loosening of the device
• Rapid joint disease, bone absorption, osteopenia, and/or • Cerebral spinal fluid leakage. before the healing process is complete, which may result in heat generated from the curing process may also cause
osteoporosis. Osteoporosis is relative since this condition • Haemorrhage and/or hematoma. further injury or the need to remove the device prematurely. neurologic damage and bone necrosis.
Important Information cont Important Safety Information

POSTOPERATIVE support devices, discomfort or abnormal sensations, infection, INDICATIONS APPLICATION NOTES
• The physician’s postoperative directions and warnings to the or bone loss. NANOSTIM™ IS USED IN ORTHOPEDICS, In fractures, proper reduction with appropriate fixation and
patient and the corresponding patient compliance, are TRAUMATOLOGY, AND NEUROSURGERY stabilization measures is an essential prerequisite for bone
extremely important. PACKAGING For the filling and reconstruction of bone defects, e. g., due to: healing.
• Detailed instructions on the use and limitations of the device Packages for each of the components should be intact upon • fractures, In unstable bone defects it is absolutely essential to use
should be given to the patient. receipt. Once the seal on the sterile package has been broken, • resection of benign tumors, NANOSTIM™ only in combination with adequate fixation or
• If partial weight bearing is recommended or required prior to the product should not be re-sterilized. Damaged packages or stabilization measures. Fixation should only be removed when
• cysts,
firm bony union, the patient must be warned that bending, products should not be used, and should be returned to imaging has confirmed sufficient consolidation of the fracture.
• harvesting of autogeneic bone grafts,
loosening, and/or breakage of the device(s) are Medtronic. NANOSTIM™ application requires a well vascularized, vital
• for filling of osteoporotic metaphyseal bone defects as
complications which may occur as result of early or excessive osseous bed. It has been noted that water may condense on
well as
weight-bearing or muscular activity. The risk of bending, STERILIZATION the inside of the aluminum bag (inner packaging). This does
loosening, or breakage of temporary internal fixation device • for bone graft extension in autogenous and allogeneic not affect product safety.
during postoperative rehabilitation may be increased if the The CORNERSTONE-SR Ti-Coated Cervical Fusion System cancellous bone transplantation.
patient is active, or if the patient is debilitated, demented, or implants are supplied in a sterile form. Never autoclave or in SIDE EFFECTS
any other way attempt to re-sterilize or re-use the MECHANISM OF ACTION
otherwise unable to use collars or other weight support In rare cases increased wound secretion may delay healing.
CORNERSTONE-SR Ti-Coated Cervical Fusion System implants. NANOSTIM™ does not harden and its structure acts as a This is particularly true for NANOSTIM™ spillover into the
devices.
matrix for the newly developing bone (osteoconductive adjacent soft tissues, or when the soft tissue covering the
• The patient should be warned to avoid falls or sudden jolts effect). The new bone will fill the defect quickly and
or shock to the spine. PRODUCT COMPLAINTS bone defect is rather thin. Therefore, due to the thin layer of
completely, with NANOSTIM™ either being resorbed or soft tissue the application of NANOSTIM™ with hallux valgus
• To allow the maximum chances for a successful surgical Any health care professional (e.g., customer or user of this integrated into the patient‘s bone tissue.
system of products) who has any complaints or who has and metatarsal arthrodesis is not recommended.
result, the device should not be exposed to mechanical
vibrations that may loosen the device construct. The patient experienced any dissatisfaction in the product quality, identity, CONTRAINDICATIONS INTERACTIONS
should be warned of this possibility and instructed to limit durability, reliability, safety, effectiveness, and / or NANOSTIM™ should not be applied or administered under
performance, should notify the distributor, Medtronic. Further, No interactions of NANOSTIM™ with other medical devices,
and restrict physical activities, especially lifting and twisting the following conditions: drugs, materials, and techniques have been observed.
motions and any type of sport participation. if any of the implanted CORNERSTONE-SR® Ti-Coated Cervical
• Acute or chronic infections at the implant site, NANOSTIM™ is MRI positive due to its water content and does
Fusion System devices “malfunctions”, (i.e., does not meet any
• The patient should be advised not to smoke or consume • Bone defects due to malignant tumors, not present a risk in magnetic resonance imaging. All metal
of its performance specifications or otherwise does not
excess alcohol during the bone graft healing process. • Bone defects at open epiphyseal plates. parts of the applicators are radiopaque.
perform as intended), or is suspected of doing so, the
• The patient should be advised of the inability to bend at the distributor should be notified immediately. If any Medtronic
point of spinal fusion and taught to compensate for this Particular caution is indicated in patients with metabolic CAUTIONS AND WARNINGS
product ever malfunctions and may have caused or bone disorders. In such cases the attending physician
permanent physical restriction in body motion. contributed to the death or serious injury of a patient, the Since NANOSTIM™ should not spill into soft tissue, bone
should undertake a risk-benefit assessment prior to defects should not be overfilled with NANOSTIM™.
• Failure to immobilize a delayed non-union of bone will result distributor should be notified as soon as possible by application.
in excessive and repeated stresses on the implant. By the telephone, fax, or written correspondence. When filing a In order to prevent the risk of embolism do not apply
mechanism of fatigue, these stresses can cause the eventual complaint, provide the component(s) name and number, lot PREGNANCY AND LACTATION NANOSTIM™ under pressure in tightly confined defects with
loosening, bending, or breakage of the device. It is important number(s), your name and address, the nature of the open venous or arterial access.
No studies have been done in pregnant or nursing patients.
that immobilization of union is established and confirmed by complaint, and notification of whether or not a written report In patients with increased wound secretion, e.g., patients on
Therefore, the attending physician should undertake a
roentgenographic examination. If a non-union develops or if from the distributor is requested. anticoagulants, the implant site should be drained.
risk-benefit assessment prior to application of NANOSTIM™.
the components loosen, bend, and/or break, the device
should be revised and/or removed immediately before There have been isolated reports of transient fever in children
MRI Information PEDIATRIC AND ELDERLY PATIENTS
serious injury occurs. after the application of NANOSTIM™, which resolved within 48
The CORNERSTONE-SR® Ti-Coated Cervical Fusion System has Presently, there are no reports that patient age would hours after surgery. It is not known if this was nonspecific
• The CORNERSTONE-SR® Ti-Coated Cervical Fusion System mandate particular precautions. postoperative fever or a reaction to NANOSTIM™.
not been evaluated for safety, heating, migration, or
implants are internal fixation devices intended to stabilize the
compatibility in the magnetic resonance environment.
operative site during the normal healing process.
• Any retrieved devices should be treated in such a manner
that reuse in another surgical procedure is not possible. FURTHER INFORMATION
Recommended directions for use of this system (surgical
operative techniques) are available at no charge upon request.
REMOVAL OF SUPPORT INSTRUMENTATION
If further information is needed or required, contact
While the CORNERSTONE-SR® Ti-Coated Cervical Fusion Medtronic.
System must remain in place, since grafting will prevent its
© 2014 Medtronic Sofamor Danek USA, Inc. All rights reserved.
removal, there may be reasons for removal of any other jointly
used internal support instrumentation after fusion has taken
place. This may particularly be the case where there is
evidence or indication of corrosion, localized tissue reaction or
pain, breakage, bending, fracture, or loosening of these
NOT FOR DISTRIBUTION IN THE U.S.A. OR ITS TERRITORIES
GIES
APIES
NOLO
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UC201405323EE - PMD013154-1.0 ©2014 Medtronic Inc. All Rights Reserved. Printed in Europe. Not for distribution in France.
Medtronic Medtronic International Trading Sàrl The surgical technique shown is for il-
Spinal and Biologics Business Case Postal lustrative purposes only. The technique(s)
Worldwide Headquarters Route du Molliau 31 actually employed in each case will
CH-1131 Tolochenaz always depend upon the medical judg-
2600 Sofamor Danek Drive
Tel. +41 (0)21 802 70 00 ment of the surgeon exercised before and
Memphis, TN 38132
Fax +41 (0)21 802 79 00 during surgery as to the best mode of
For more information visit treatment for each patient.
www.myspinetools.com
Please see the package insert for the
complete list of indications, warnings,
precautions, and other important medical
Medtronic Sofamor Danek USA, Inc. information.
1800 Pyramid Place
Memphis, TN 38132
(901) 396-3133
(800) 876-3133
Customer Service: (800) 933-2635
www.medtronic.com www.medtronic.eu

medtronic - Compact Cornerstone

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medtronic - Compact Cornerstone

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INL NO.

A8541 PROJECT Medtronic DESCRIPTION spine_compact_cornerstone_3implants_ST_updates

Not for use in the

Surgical Exposre and Distraction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Neurological Dicompression and Trialing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Implant Inserter Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Bone Grafting Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Implantation and Explantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Product Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11

Important product Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Implant Features Surgical Exposure and Distraction

COMPACT CORNERSTONE-SR® SURGICAL EXPOSURE

Surgical approach to the targeted cervical disc is carried out with a

DISTRACTION (3-STEP PROCEDURE)

• 4 Titanium Fixation Spikes

Neurological Decompression and Trialing Instrument Sets

NEUROLOGICAL DECOMPRESSION IMPLANT INSERTER ASSEMBLING

Prior fluoroscopic control is recommended to assess disc height and

The appropriate size implant is chosen from the trialing step.

Begin by inserting the threaded hole of the cage

Press the cage in the direction of the inserter shaft.

Bone Grafting Solutions Instrument Sets

AUTOGENOUS BONE IMPLANTATION

NANOSTIM™ SYNTHETIC BONE PASTE EXPLANTATION

If using NANOSTIM™ Synthetic Bone Paste as an autograft extender

Product Ordering Information

IMPLANTS OPTIONAL IMPLANTS INSTRUMENT SET OPTIONAL INSTRUMENT SET

Product Ordering Information

IMPLANTS OPTIONAL IMPLANTS

COMPATIBLE WITH THE 3 CAGES

Important Information Important Information cont

Important Information cont Important Safety Information

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