Kyphoplasty systems
Puncture Needle
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.
Puncture Needle 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 |
|---|---|---|---|
| FG3001 | Outer Diameter 3 mm | Not stated | Available |
| FG3002 | Outer Diameter 3 mm | Not stated | Available |
| FG3003 | Outer Diameter 3 mm | Not stated | Available |
| FG3004 | Outer Diameter 2.5 mm | Not stated | Available |
| FG3005 | Outer Diameter 3 mm | Not stated | Available |
| FG3006 | Outer Diameter 3 mm | Not stated | Available |
| FG3007 | Outer Diameter 2.5 mm | Not stated | Available |
| FG3008 | Outer Diameter 3 mm | Not stated | Available |
| FG3009 | Outer Diameter 3 mm | Not stated | Available |
| FG3010 | Outer Diameter 2.5 mm | Not stated | Available |
| FG3011 | Outer Diameter 2.5 mm | Not stated | Available |
FDA clearances
- 510(k) K113742 September 2012
Procedures that use kyphoplasty systems
Frequently asked questions
What is Puncture Needle 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 Puncture Needle?
Puncture Needle 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 Puncture Needle come in?
Sizes listed for Puncture Needle: Outer Diameter: 2.5–3 mm. Confirm availability with the manufacturer's instructions for use.
Is Puncture Needle MRI safe?
The FDA device database entry for Puncture Needle does not state its MRI safety status. Check the labeling before MRI.
Is Puncture Needle FDA cleared?
Puncture Needle 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.