0380075E Rev. A
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132, USA
Telephone 800 933 2635 (In U.S.A.)
901 396 3133 (Outside U.S.A.)
Fax 901 396 0356
0123
2012-10-09
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
ATLAS™ CABLE SYSTEM
IMPORTANT INFORMATION ON
ENGLISH
THE ATLAS™ CABLE SYSTEM
PURPOSE
The ATLAS™ Cable system is a temporary implant for the use in orthopaedic and cardiovascular
surgery. The system is intended to help provide temporary stabilization, augment the development of
solid bony fusion and/or aid in the repair of bone fractures.
DESCRIPTION
The system consists of a multi-stranded cable in several configurations.
The ATLAS™ Cable System implant components are made of medical grade stainless steel described
by ASTM Standard F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, the system may be made out of
titanium alloy or titanium, as described in ASTM F-136 or ISO 5832-3 for the surgical grade titanium
alloy and ASTM F 67 or ISO 5832-2 for pure titanium. The material type will be on the label. Stainless
steel and titanium implant components must not be used together in a construct. MEDTRONIC
SOFAMOR DANEK expressly warrants that these devices are fabricated from the foregoing material
specifications. No other warranties, express or implied, are made.
INDICATIONS, CONTRAINDICATIONS, AND
POSSIBLE ADVERSE EFFECTS:
Properly used, this device will aid in the repair or attachment of bony structures. The indications and
contraindications of this system should be well understood by the surgeon. The system is indicated for
use whenever a conservative or a non-implant surgery is deemed insufficient to improve the medical
condition of the patient.
The ATLAS
be indicated. The indications are:
™
Cable System can be utilized anywhere monofilament wire has been previously found to
1. Spinal applications would include sublaminar and intraspinous process wiring for trauma
applications. Another application would be the use of the ATLAS™ Cable System for
instrumentation involved in the correction of scoliotic, kyphotic, and lordotic deformities. The
stainless steel system may also be used with other stainless steel spinal implants such as the Unit
pg. 1 of 7
Rod or Luque Rod or wherever “wiring” may help secure the attachment of other implants. The
titanium system may also be used with other titanium implants.
2. Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
3. Sternotomy indications would include the “re-wiring” of osteomizing sternums.
4. Trauma surgery indications would include olecranon, ankle, patella, and some shoulder fracture
rewiring.
CONTRAINDICATIONS:
Contraindications include, but are not limited to:
1. Presence of overt infection and/or localized inflammation.
2. Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative
contraindication since this condition may limit the degree of obtainable correction and the amount
of mechanical fixation.
3. Suspected or documented metal allergy or intolerance.
4. Any patient having inadequate tissue coverage over the operative site.
5. Any time implant utilization would interfere with anatomical structures or expected physiological
performance, such as impinging on vital structures.
6. Severe commuted fractures such that segments may not be maintained in satisfactory proximate
reduction, i.e. “cannonball” fractures.
7. The presence of marked bone absorption or severe metabolic bone disease that could compromise
the fixation achieved.
8. Any other medical or surgical condition which would preclude the potential benefit of surgery, such
as elevation of sedimentation rate unexplained by other diseases, elevation of white blood count
(WBC), fever, leukocytosis, or a marked left shift in the WBC differential count.
9. If the stainless steel version is used, the physical contact of the ATLAS™ Cable System with any
metal implant made of anything other than implant grade stainless steel.
10.If the titanium or titanium alloy version is used, the physical contact of the ATLAS™ Cable with any
metal implant made of anything other than implant grade titanium.
™
11.The combination of the ATLAS
12.Any case not described in the indications.
Cable with monofilament wire.
POSSIBLE ANTICIPATED ADVERSE EFFECTS:
1. Early or late loosening of the components.
2. Disassembly, fraying, kinking, loosening, bending, or breaking of any or all of the components.
3. Foreign body reaction to the implants including possible tumor formation.
4. Pressure on the skin from component parts where there is inadequate tissue coverage over the
implant causing skin irritation.
5. Loss of proper curvature, correction, height, and/or reduction.
6. Infection.
7. Cables cutting through soft osteoporotic, osteopenic, or cancellous bone.
pg. 2 of 7
8. Bone forming around the implant making removal difficult or impossible.
9. Non-union (or pseudarthrosis) or bone fracture.
10.Neurovascular compromise including radiculopathy, paralysis, or other types of serious injury
causing pain.
11.Hemorrhage of blood vessels.
12.Cessation of growth of the operated portion of the bone.
13.Death.
Note: Additional surgery may be necessary to correct some of the anticipated adverse reactions.
IMPORTANT NOTE: The actual tension value should be decided by the surgeon taking into account
the condition and quality of the patient’s bone. However, the tension applied should never be in
excess of 60 lbs. (27kg.) (267 Newtons) for stainless steel and 35 lbs. (16kg.) (156 Newtons) for
titanium. Loads greater than this value may fracture the bone and/or damage the cable or instruments.
WARNINGS AND PRECAUTIONS:
A successful result is not always achieved in every surgical case. This fact is especially true in
orthopaedic or cardiovascular surgery where many extenuating circumstances may compromise the
results. The ATLAS™ Cable System is only a temporary implant and should only be used to augment
bony fusion or aid fracture healing. This device system is not intended to be the sole means of support.
No implant can withstand body loads without the support of bone. In this event, bending, fraying,
kinking, loosening, disassembly, and/or breakage of the device(s) will eventually occur.
Preoperative and operating procedures, including knowledge of surgical techniques, good reduction,
and proper selection and placement of the implant are important considerations in the successful
utilization of the ATLAS™ Cable System by the surgeon. Further, the proper selection of the patient
and the compliance of the patient will greatly affect the results. For some spinal cases, patients who
smoke have been shown to have an increased incidence of non-unions. These patients should be
advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse
patients are also poor candidates for surgery. Patients with poor bone quality are also poor candidates
for surgery.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the
patient, the important medical information given in this document should be conveyed to the patient.
CAUTION: FOR USE ON OR BY THE ORDER OF A PHYSICIAN ONLY.
For US Audiences Only
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER
OF A PHYSICIAN.
Other preoperative, intraoperative, and postoperative warnings are as follows:
pg. 3 of 7
Loading...