Kyphoplasty systems
Bone Filler Device
by Shanghai Kinetic Medical Co., Ltd.
A rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.
Where to buy Bone Filler Device
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.
Bone Filler Device 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 |
|---|---|---|---|
| FG2500 | — | Not stated | Available |
| FG2501 | — | Not stated | Available |
| FG2510 | Outer Diameter 3.5 mm | Not stated | Available |
| FG2512 | Outer Diameter 3.5 mm | Not stated | Available |
| FG2513 | Outer Diameter 3.5 mm | Not stated | Available |
FDA clearances
- 510(k) K113742 September 2012
Procedures that use kyphoplasty systems
Frequently asked questions
What is Bone Filler Device used for?
A rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.
Who makes Bone Filler Device?
Bone Filler Device 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 Bone Filler Device come in?
Sizes listed for Bone Filler Device: Outer Diameter: 3.5 mm. Confirm availability with the manufacturer's instructions for use.
Is Bone Filler Device MRI safe?
The FDA device database entry for Bone Filler Device does not state its MRI safety status. Check the labeling before MRI.
Is Bone Filler Device FDA cleared?
Bone Filler Device 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.