Important Information – Please Read Before Use
CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician.
INDICATIONS
The StabiliT® MX Vertebral Augmentation System is intended for percutaneous delivery of StabiliT Bone Cement.
The StabiliT Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a
vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis,
benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
DESCRIPTION
The StabiliT MX Vertebral Augmentation System is a system for the controlled delivery of StabiliT Bone Cement
in the treatment of vertebral compression fractures. The StabiliT MX Vertebral Augmentation System consists of
different combinations of the components below (Figure 1).
7a. Funnel
2. Master Syringe and
Hydraulic Coupler
3. Cement
Delivery Elbow
7b. Cement Syringe
7c. Filter
7d. Stopcock
7e. Locking Syringe
Working Length
StabiliT Introducers
4. & 5.
6. Locking Delivery Cannula with Locking Wheel
8. PowerCURVE Navigating Osteotome
9. StraightLine Osteotome
1. DiamondTOUCH™ Syringe
Working Length
Working Length
Working Length
7f. Monomer
Figure 1: StabiliT MX Vertebral Augmentation System
English
INSTRUCTIONS FOR USE
StabiliT
®
MX Vertebral
Augmentation System
with PowerCURVE
®
Navigating Osteotome
(For use with StabiliT
®
Bone Cement)