The Fixion IM Nail is expandable and does not require interlocking screws for intramedullary fixation. The Nail is inserted into the medullary canal in a reduced form. Once in position, the Nail is expanded to its intended diameter using saline solution and a pump.
FEATURES
Expanded within the medullary canal with saline solution.
Inserted in a reduced diameter.
Adapts itself to the contours of the medullary canal (hour-glass shape).
Fixation is achieved along the entire length of the nail allowing perfect positioning at fracture site.
Minimally invasive procedure.
Reaming is optional.
No interlocking screws required, thus reduced infection risk.
Minimized fluoroscopy exposure.
Reduced procedure time.
One entry point instead of the 3 skin and tissue dissections performed in standard nailing surgeries.
In humeral procedures, reduced possibility of damaging the rotator cuff.
For humeral procedures, due to its geometry and reduced diameter, the same nail may be implanted in both antegrade and retrograde approaches.
Reduces the possibility of nerve damage.
As the nail adapts to the intramedullary canal shape and diameter, a homogeneous fixation of the fracture is achieved and reduces the risk of transverse movements at the fracture site.
Immediate axial load transfer in-between the fracture fragments may contribute to faster callus formation.
Significant advantages in treating osteoporotic bone and pathological fractures.
Nail is supplied sterile.
Reduced inventory as expansion enables covering of a range of medullary canal diameters.
FIXION IM PROCEDURE
PRINCIPLES OF OPERATION
Nail is supplied in a reduced diameter configuration.
Nail is inserted into the medullary canal utilizing the insertion handle. Once in position, the Nail is expanded to its intended diameter through inflation with saline solution, utilizing the pump.
Excellent fixation is achieved through the attachment of the four longitudinal bars of the Nail to the inner wall of the medullary cavity.
INDICATIONS
Acute fractures of the humerus, tibia or femur which are 5cm below the proximal end or 5cm above the distal end of the medullary canal.
Osteotomy.
Nonunions and malunions.
Long bone reconstruction following tumor resection, grafting and prophylactic nailing of impending pathological fractures.
Revision procedures where other treatments and devices have failed.
REVISION PROCEDURE OF A CONVENTIONAL NAIL
FIXION EXPANDABLE NAIL IN A PATHOLOGICAL FRACTURE
INFORMATION
Fixion IM Humeral Nails:
Reduced Diameter
[mm]
Expanded Diameter
[mm]
Available Lengths
[mm]
Recommended for Isthmus Diameter [mm]
6.7
10.0
200, 220, 240, 260, 280
7.0 - 8.0
7.4
11.0
200, 220, 240, 260, 280
8.0 - 10.0
8.5
13.5
200, 220, 240, 260, 280
10.0 - 12.0
Fixion IM Tibial Nails:
Reduced Diameter
[mm]
Expanded Diameter
[mm]
Available Lengths
[mm]
Recommended for Isthmus Diameter [mm]
8.5
13.5
260, 280, 300, 320, 340, 360, 380, 400
10.0 - 12.0
10.0
16.0
260, 280, 300, 320, 340, 360, 380, 400
12.0 - 14.0
Fixion IM Femoral Nails:
Reduced Diameter
[mm]
Expanded Diameter
[mm]
Available Lengths
[mm]
Recommended for Isthmus Diameter [mm]
8.5
13.5
320, 340, 360, 380, 400, 420, 440
10.0 - 12.0
10.0
16.0
320, 340, 360, 380, 400, 420, 440
12.0 - 14.0
12.0
19.0
320, 340, 360, 380, 400, 420, 440
14.0 - 17.0
The devices are CE marked and cleared for marketing by the FDA. Caution: Federal law (U.S.A.) restricts these devices to sale by or on the order of a physician.