Product Information

1. Bioflex Semirigid Stabilization for Fusion Technology
   - Semirigid Fixation System
   Strong support for better physiologic fusion
   Fusion without stress shield effect.
2. Bioflex Dynamic Stabilization for Non-fusion Technology
   - Dynamic Stabilization System
   Preserving motion while maintaining sagittal balance when flexion, extension, lateral bending, and rotation.
   Prevent adjacent segment degeneration
3. Bioflex Hybrid Balanced Stabilization
   - Semirigid Fixation System + Dynamic Stabilization System
   Semirigid Fusion for Main Pathologic Segment
   Dynamic Stabilization for
   1) prevention of adjacent segmental degeneration
   2) restoration of sagittal balance
   Correction for spinal deformity (Degenerative Kyphoscoliosis)
4. Inter-vertebral fusion cage
   - The Bio Expandable cage has little risk of subsidence while the stand-aline cage has little risk of cage migration with subsequent loosening.
   The surface of the cage is coated with hydroxyapatite and is more porous than other similar cages. The hydroxyapatite coatings can promote the formation of normal bone at its surface and have osteo-conductive and osteo-integrative effect.

[Innovation Features]

1. The alternative to traditional rigid system : Hybrid Stabilization System (Dynamic Stabilization System, Semirigid Fixation System)
2. The innovative devices in Spinal Fixation System, particularly Posterior Stabilization System.
3. 4mm diameter Nitinol / Titanium alloy coiled springs : Nitinol Spring Rod System
4. Natural 3-D balance by Nitinol Spring Rods System and Pedicle Screw System
5. The prevention of degeneration of adjacent segments.
6. Reduced instrumentation failures.

[Surgical Advantages]

1. Multilevel segmental connection
2. Easy to use
3. No Rod bending
4. Low profile device
5. Minimal invasive surgical Insertion]

[Surgical Procedures]

Surgical Procedures Step

[Step 01 Pedicle Identification]
Puncture holes in the surgical points of the pedicle using an awl. (See Fig. 1-1, 1-2, 1-3)
Assure adequate length with the probe and the tester.

[Step 02 Screw Insertion]
Fasten pedicle screws with screw driver(extra screw driver included to reduce operating time) Insert pedicle screws so that the screw heads are properly aligned. (See Fig.2-1)
The direction of the screw alignment handle is a helpful guide in aligning the screw heads. (See Fig.2-2)

[Step 03 Rod Insertion]
Insert the rods into the screw head with the small rod holder.
Place the set screw on the set screw driver onto the pedicle screw.
Insert the set screw driver into the rod pusher and lightly fasten the set screws, with the rods placed arbitrarily.(See Fig.3-1)
Start with the center screw. (See Fig. 3-2)
NOTE: The dextral rod's coil turns clockwise, while the opposite rod's coil turns counter clockwise.

[Step 04 Rod Alignment]
Using the rod holder, turn the rod so that the coil 'stands up'. The center of the rod's coil should be aligned with the rod-placement line.
For distraction and compression, use the spreader and compressor respectively and accordingly. (See Fig. 4-1, 4-2)

[Step 05 Tightening and Alignment]
Tightly fasten set screws using anti-torque driver and set screw driver.
Use rod pusher to twist the pedicle screws for a balanced alignment of the rod.(See Fig. 5-1, 5-2)

[Clinical Conclusions]

BioFlex Spring Rod System
This system is flexible but strong enough to support, and thus can reduce undesirable effects of the rigid system, reconstruct the sagittal balance while simultaneously maintaining segmental movement, and achieve more uniform disc unloading and preservation of motion in flexion, extension, lateral bending and rotation.

Nitinol Spring Rod System + Pedicle Screw System => Hybrid Stabilization System
(Dynamic Stabilization System + Semirigid Fixation System)

Product