Kyphoplasty systems
Tracker
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 Tracker
We do not have contact details for GS Medical Co., Ltd. yet. Send a request and we will route it to the right person for your country.
Tracker 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 |
|---|---|---|---|
| GCD-1.5KIT-E | — | Not stated | Available |
| GCD-CA1-E | — | Not stated | Available |
| GCD-EX1-E | — | Not stated | Available |
| GCD-ND1-E | — | Not stated | Available |
| GCD-NP1-E | — | Not stated | Available |
| GCD-SP1-E | — | Not stated | Available |
| GCD-WP1-E | — | Not stated | Available |
| GCD2-CF1-E | — | Not stated | Available |
| GCD2-CP1-E | — | Not stated | Available |
| GSK-10-E | — | Not stated | Available |
| GSK-15-E | — | Not stated | Available |
| GSK-20-E | — | Not stated | Available |
| GSK-BOO-E | — | Not stated | Available |
FDA clearances
- 510(k) K192335 December 2019
Procedures that use kyphoplasty systems
Frequently asked questions
What is Tracker 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 Tracker?
Tracker is made by GS Medical Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Tracker come in?
The FDA device database does not list sizes for Tracker. Check the instructions for use or ask a GS Medical Co., Ltd. representative.
Is Tracker MRI safe?
The FDA device database entry for Tracker does not state its MRI safety status. Check the labeling before MRI.
Is Tracker FDA cleared?
Tracker is covered by FDA submission K192335.
How do I contact a GS Medical Co., Ltd. sales representative?
GS Medical Co., Ltd. has not listed representatives on LA Vascular yet. Visit the GS 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.