Capstone™ Spinal System M708348B447E Rev. C
2020-10-01
IMPORTANT INFORMATION ON THE CAPSTONE™ SPINAL SYSTEM
PURPOSE
This device is a fusion device intended for stabilization and to promote bone fusion during the normal healing process following
surgical correction of disorders of the spine. The product should be implanted only by a physician thoroughly knowledgeable in
the implant’s material and surgical aspects and instructed as to its mechanical and material applications and limitations.
DESCRIPTION
The Capstone™ Spinal System consists of PEEK cages, titanium alloy cages, and titanium cages of various widths and heights,
which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar
interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft
bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow
aspirate.
No warranties express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are
specifically excluded.
INDICATIONS
The Capstone™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc
Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or
retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history
and radiographic studies. When used for these indications, the Capstone
fixation systems cleared for use in the lumbar spine.
Additionally, the Capstone
degenerative scoliosis as an adjunct to pedicle screw fixation.
These patients should be skeletally mature and have had six months of nonoperative treatment. The Capstone
is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone
graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion.
These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also
be implanted via an anterior and/or transforaminal approach.
™
Spinal System can be used to provide anterior column support in patients diagnosed with
™
Spinal System is intended for use with supplemental
™
Spinal System
CONTRAINDICATIONS
This device is not intended for cervical spine use.
Contraindications include:
▪ Infection local to the operative site
▪ Signs of local inflammation
▪ Fever or leukocytosis
▪ Morbid obesity
▪ Pregnancy
▪ Mental illness
▪ Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or
congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases,
elevation of white blood count (WBC), or a marked left shift in the WBC differential count
▪ Suspected or documented allergy or intolerance to composite materials
▪ Any case not needing a fusion
▪ Any case not described in the indications
▪ Any patient unwilling to cooperate with postoperative instructions
▪ Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of
surgery
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth
▪ Spondylolisthesis unable to be reduced to Grade 1
▪ Any case where implant components selected for use would be too large or too small to achieve a successful result
▪ Any case that requires the mixing of metals from two different components or systems
▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
▪ Any patient in which implant use would interfere with anatomical structures or expected physiological performance
▪ Prior fusion at the level to be treated
NOTA BENE: Although not absolute contraindications, conditions to be considered as potential factors for not using this device
include:
▪ Severe bone resorption
▪ Osteomalacia
▪ Severe osteoporosis
POTENTIAL ADVERSE EVENTS
Adverse effects may occur when the device is used either with or without associated instrumentation. The risk of adverse effects
as a result of movement and non-stabilization may increase in cases where associated complementary support is not employed.
Potential adverse events include:
▪ Implant migration
▪ Breakage of the device(s)
▪ Foreign body reaction to the implants including possible tumor formation, auto immune disease, and scarring
▪ Pressure on the surrounding tissues or organs
▪ Loss of proper spinal curvature, correction, height, and reduction
▪ Infection
▪ Bone fracture or stress shielding at, above, or below the level of surgery
▪ Non-union (or pseudoarthrosis)
▪ Loss of neurological function, appearance of radiculopathy, dural tears, and development of pain
▪ Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, or other types of
serious injury
▪ Cerebral spinal fluid leakage
▪ Haemorrhage of blood vessels and hematomas
▪ Discitis, arachnoiditis, and or other types of inflammation
▪ Deep venous thrombosis, thrombophlebitis, and pulmonary embolus
▪ Bone graft donor site complication
▪ Inability to resume activities of normal daily living
▪ Early or late loosening or movement of the device(s)
▪ Urinary retention, loss of bladder control, or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and pain
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and
vertebral body) and bone graft or bone graft harvest site at, above, or below the level of surgery
▪ Retropulsed graft
▪ Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery
▪ Loss of or increase in spinal mobility or function
▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction
▪ Development of respiratory problems (e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.)
▪ Change in mental status
▪ Cessation of any potential growth of the operated portion of the spine
▪ Death
WARNINGS AND PRECAUTIONS
A device that has been implanted should never be reused or reprocessed under any circumstances. Sterile packaged devices
should also never be resterilized. Reuse or eprocessing may compromise the structural integrity of these implants and create a
risk of contamination of implants which could result in patient injury, illness, or death.
When used in deformity procedures, undersizing the implant may limit endplate engagement and potentially lead to implant
migration and/or expulsion.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other
patient conditions may compromise the results. Use of this product without autogenous bone and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or
in cases that do not develop a union will not be successful.
Preoperative and operating procedures including knowledge of surgical techniques, good reduction, and correct selection and
placement of implants are important considerations in the successful use of the system. Further, proper selection and
compliance of the patient will greatly affect results. Patients who smoke were shown to have a reduced incidence of bone
fusion. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, or alcohol/drug
abuse patients, and those with poor muscle and bone quality and nerve paralysis are also poor candidates for spinal fusion.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without
a previous spinal surgery.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the patient, the important
medical information in this document should be conveyed to the patient.
FOR US AUDIENCES ONLY
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER
OF A PHYSICIAN.
MRI INFORMATION
MR Conditional
The Capstone™ Spinal System was determined to be MR-Conditional based on non-clinical testing and engineering rationales.
A patient with this device can be safely scanned immediately after device placement under the following conditions:
Static Magnetic Field
▪ Static magnetic field of 1.5 Tesla and 3.0 Tesla
▪ Maximum spatial gradient magnetic field of 3000-Gauss/cm (30 T/m) or less
▪ Maximum whole body average specific absorption rate (SAR) of 2.0 -W/kg or less under
▪ Normal Operating Mode, for 15 minutes of scanning per pulse sequence
Under the scan conditions defined, a worst-case interbody fusion device representative of the Capstone™ Spinal System
produced a maximum temperature rise of 4.4 °C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by a worst-case interbody fusion device representative of the Capstone™
Spinal System extends approximately 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0 Tesla
MR system. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be
necessary.
If Capstone™ Spinal System is used in connection with any device which is not MR Conditional, please be advised that this
combination has not been tested in the MR environment and, therefore, higher heating and possible injury to the patient may
occur. The presence of other implants or the health state of the patient may require a modification of the MR conditions.
IMPLANT SELECTION
Selection of proper size, shape, and design of the implant for each patient is crucial to success of the procedure. Surgical
implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the human
anatomy. Unless great care is taken in patient selection, placement of the implant, and postoperative management to minimize
stresses on the implant, such stresses may cause material fatigue and consequent breakage or loosening of the device before
the fusion process is complete, which may result in further injury or the need to remove the device prematurely.
DEVICE FIXATION
Installation and positional adjustment of implants must only be done with special ancillary instruments and equipment supplied
and designated by Medtronic. In the interests of patient safety, it is therefore recommended that Medtronic implants are not
used with devices from any other source.
Never, under any circumstances, reuse a Capstone
undamaged, it may have small defects or internal stress patterns that may lead to early breakage.
™
Spinal System device. Even when a removed device appears
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected
▪ Patient conditions and predispositions such as those addressed in the contraindications should be avoided
▪ Care should be taken when handling and storing the device(s). They should not be scratched or damaged. Devices should
be protected during storage especially from corrosive environments.
▪ The surgeon should be familiar with the various devices before use and should personally verify all devices are present
before surgery.
▪ The size of device for the case should be determined prior to surgery. An adequate inventory of implant sizes should be
available at the time of surgery including sizes larger and smaller than those expected to be used.
▪ Unless supplied sterile, all devices should be cleaned and sterilized before use. Additional sterile components should be
available in case of any unexpected need.
INTRAOPERATIVE
▪ Instructions in any available Capstone
™
Spinal System surgical technique manual should be carefully followed.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves will cause loss of
neurological functions.
▪ Breakage, slippage, or misuse of instruments or implants may cause injury to the patient or operative personnel
▪ To ensure proper fusion below and around the location of the fusion, autogenous bone and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow
aspirate must be used
▪ When used via a posterior approach, supplemental posterior instrumentation is recommended. Posterior supplemental
fixation is limited to Medtronic posterior instrumentation systems.
▪ Bone cement should not be used because this material may make removal of these components difficult or impossible.
Heat generated from the curing process may damage or deform the PEEK devices.
POSTOPERATIVE
The physician’s postoperative directions and warnings to the patient, as well as the corresponding patient’s compliance are
extremely important.
▪ Detailed instructions on the use and limitations of the device should be given to the patient. The patient must be warned
that loosening and breakage of the device(s) are complications which may occur as result of early or excessive weightbearing, muscular activity, or sudden jolts or shock to the spine.
▪ The patient should be advised not to smoke or consume excess alcohol during period of the bone fusion process
▪ The patient should be advised of the inability to bend at the point of spinal fusion and taught to compensate for this
permanent physical restriction in body motion
▪ It is important that immobilization of union is established and confirmed by roentgenographic examination. If a non-union
develops or if the components loosen, migrate, or break, the devices should be revised and/or removed immediately before
serious injury occurs.
▪ Capstone
process
™
Spinal System implants are interbody devices and are intended to stabilize the operative area during the fusion
▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible
PACKAGING
Devices may be supplied sterile or non-sterile. Packages for each of the components should be intact upon receipt. Once the
seal on the sterile package is broken, the product should not be re-sterilized. If a loaner or consignment system is used, all sets
should be carefully checked for completeness and all components, including instruments, should be carefully checked to ensure
there is no damage prior to use. Damaged packages or products should not be used and should be returned to Medtronic.
CLEANING AND DECONTAMINATION
Specific types of instruments, such as inserters, may have reprocessing instructions enclosed within the product packaging.
Refer to these detailed instructions for further information on the general considerations, cleaning, and sterilization procedures.
These reprocessing instructions can also be found at http://manuals.medtronic.com/ according to the product part number.
STERILIZATION
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by Medtronic, all implants and
instruments used in surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization.
Only sterile products should be placed in the operative field. Unless specified elsewhere, these products are recommended to
be steam sterilized by the hospital using one of the sets of parameters in Table 1.
Table 1: Sterilization Cycle Parameters for the US and Its Territories
METHOD CYCLE TEMPERATURE EXPOSURE TIME
Steam Gravity Displacement 250°F (121°C) 30 Minutes 30 Minutes
Steam Gravity Displacement 270°F (132°C) 15 Minutes 30 Minutes
Steam Gravity Displacement 275°F (135°C) 10 Minutes 30 Minutes
Steam Dynamic-Air-Removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-Air-Removal 275°F (135°C) 3 Minutes 16 Minutes
For medical facilities located outside the US and its territories, some non-US health care authorities recommend sterilization
according to these parameters to minimize the risk of transmission of Creutzfeldt-Jakob disease, especially of surgical
instruments that could come into contact with the central nervous system.
Table 2: Sterilization Cycle Parameters for Medical Facilities Outside the US and Its Territories
METHOD CYCLE TEMPERATURE EXPOSURE TIME
Steam Gravity Displacement 273°F (134°C) 20 Minutes 30 Minutes
Steam Dynamic-Air-Removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-Air-Removal 273°F (134°C) 20 Minutes 30 Minutes
1
Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient atmospheric
pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.
NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment.
The sterilization cycles listed in Table 2 are not considered by the FDA to be standard sterilization cycles. It is the user’s
responsibility to use only sterilizers and accessories (i.e. sterilization wraps, sterilization pouches, chemical indicators, biological
indicators, and sterilization cassettes) cleared by the FDA for the selected sterilization cycle specifications (time and
temperature).
Specific types of instruments, such as inserters, may have reprocessing instructions enclosed within the product packaging.
Refer to these detailed instructions for further information on the general considerations, cleaning, and sterilization procedures.
These reprocessing instructions can also be found at http://manuals.medtronic.com/ according to the product part number.
MINIMUM DRY TIME
MINIMUM DRY TIME
1
1
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.
©2020 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Do not re-use
Use-by date
Batch code
Catalogue number
Non-sterile
For US audiences only
Manufacturer
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
This device complies with applicable European Union
regulations and directives.
Authorized representative in the European Community
Sterilized using irradiation
Consult instructions for use at this website.
MR Conditional
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