Kyphoplasty systems
Concord
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.
Where to buy Concord
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.
Concord 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 |
|---|---|---|---|
| 458.693S | — | Not stated | Available |
| 4129.2000S | Weight 20 g | Not stated | Available |
| 4129.2020S | — | Not stated | Available |
| 4129.4000S | Weight 40 g | Not stated | Available |
| 4129.4040S | — | Not stated | Available |
FDA clearances
- 510(k) K162618 January 2017
- 510(k) K042168 January 2005
Procedures that use kyphoplasty systems
Frequently asked questions
What is Concord used for?
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.
Who makes Concord?
Concord is made by Globus Medical, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Concord come in?
Sizes listed for Concord: Weight: 20–40 g. Confirm availability with the manufacturer's instructions for use.
Is Concord MRI safe?
The FDA device database entry for Concord does not state its MRI safety status. Check the labeling before MRI.
Is Concord FDA cleared?
Concord is covered by FDA submissions K042168, K162618.
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.