Kyphoplasty systems

Drill

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.

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Where to buy Drill

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Drill models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
FG2110Length 220 mm; Outer Diameter 3.5 mm Not statedAvailable
FG2111Length 200 mm; Outer Diameter 3.5 mm Not statedAvailable

FDA clearances

  • 510(k) K113742 September 2012

Procedures that use kyphoplasty systems

Frequently asked questions

What is Drill 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 Drill?

Drill 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 Drill come in?

Sizes listed for Drill: Length: 200–220 mm; Outer Diameter: 3.5 mm. Confirm availability with the manufacturer's instructions for use.

Is Drill MRI safe?

The FDA device database entry for Drill does not state its MRI safety status. Check the labeling before MRI.

Is Drill FDA cleared?

Drill 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.

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