Kyphoplasty systems
Synth Standard
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 Synth Standard
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Synth Standard 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 |
|---|---|---|---|
| SYNTH-SSU | — | Not stated | Available |
| SYNTH-SSU10 | — | Not stated | Available |
| SYNTH-SSU10D | — | Not stated | Available |
| SYNTH-SSU20 | — | Not stated | Available |
| SYNTH-SSU20D | — | Not stated | Available |
| SYNTH-SSUD | — | Not stated | Available |
FDA clearances
- 510(k) K153296 July 2016
Procedures that use kyphoplasty systems
Frequently asked questions
What is Synth Standard 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 Synth Standard?
Synth Standard is made by Imedicom Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Synth Standard come in?
The FDA device database does not list sizes for Synth Standard. Check the instructions for use or ask a Imedicom Co., Ltd. representative.
Is Synth Standard MRI safe?
The FDA device database entry for Synth Standard does not state its MRI safety status. Check the labeling before MRI.
Is Synth Standard FDA cleared?
Synth Standard is covered by FDA submission K153296.
How do I contact a Imedicom Co., Ltd. sales representative?
Imedicom Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Imedicom 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.