Kyphoplasty systems
Shield
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Where to buy Shield
We do not have contact details for Globus Medical, Inc. yet. Send a request and we will route it to the right person for your country.
Shield 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 |
|---|---|---|---|
| 4129.1015S | Length 15 mm | Not stated | Available |
| 4129.1020S | Length 20 mm | Not stated | Available |
| 4129.1025S | Length 25 mm | Not stated | Available |
FDA clearances
- 510(k) K093477 December 2011
Procedures that use kyphoplasty systems
Frequently asked questions
What is Shield used for?
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Who makes Shield?
Shield is made by Globus Medical, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Shield come in?
Sizes listed for Shield: Length: 15–25 mm. Confirm availability with the manufacturer's instructions for use.
Is Shield MRI safe?
The FDA device database entry for Shield does not state its MRI safety status. Check the labeling before MRI.
Is Shield FDA cleared?
Shield is covered by FDA submission K093477.
How do I contact a Globus Medical, Inc. sales representative?
Globus Medical, Inc. has not listed representatives on LA Vascular yet. Visit the Globus Medical, Inc. 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.