SKY Spinal Kyphoplasty System
Vertebral augmentation
Balloon-based spinal kyphoplasty system and accessories for vertebral augmentation procedures.
- Product type
- Kyphoplasty system
- Application
- Vertebral augmentation
- Material / Platform
- Procedure kit with multiple accessory components; component materials vary by accessory.
- Regulatory
- TFDA No. 007712
Product Overview
A kyphoplasty system used for vertebral compression-fracture procedures. The balloon catheter is used to create or restore space within cancellous bone before PMMA bone cement is introduced using appropriate cement-delivery instrumentation.
Design & product features
Kyphoplasty balloon catheter
Pressure injector
Guide wire and access components
Drill and related procedural accessories
Models & Specifications
Available configurations within this product family. Refer to the current approved IFU and labeling for final model selection.
| Configuration | Details |
|---|---|
| 01 | Multiple balloon sizes |
| 02 | Dedicated access and guide components |
| 03 | Procedure-specific accessory configurations |
EO sterilized system components; supplied in individually sterile packaging as specified in the IFU.
Indications Overview
The points below summarize the approved product family. Final patient selection and surgical use must follow the applicable approved Instructions for Use.
- Vertebral compression fracture applications as specified in the approved IFU
- Creation of space within cancellous vertebral bone
- Use with PMMA bone cement during kyphoplasty
Product Visualization