Kyphoplasty systems
Tool Kit
by Shanghai Kinetic Medical Co., Ltd.
A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.
Where to buy Tool Kit
We do not have contact details for Shanghai Kinetic Medical Co., Ltd. yet. Send a request and we will route it to the right person for your country.
Tool Kit models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| FG2001 | — | Not stated | Available |
| FG2002 | — | Not stated | Available |
FDA clearances
- 510(k) K113742 September 2012
Procedures that use kyphoplasty systems
Frequently asked questions
What is Tool Kit used for?
A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.
Who makes Tool Kit?
Tool Kit is made by Shanghai Kinetic Medical Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Tool Kit come in?
The FDA device database does not list sizes for Tool Kit. Check the instructions for use or ask a Shanghai Kinetic Medical Co., Ltd. representative.
Is Tool Kit MRI safe?
The FDA device database entry for Tool Kit does not state its MRI safety status. Check the labeling before MRI.
Is Tool Kit FDA cleared?
Tool Kit is covered by FDA submission K113742.
How do I contact a Shanghai Kinetic Medical Co., Ltd. sales representative?
Shanghai Kinetic Medical Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Shanghai Kinetic Medical Co., Ltd. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.