Kyphoplasty systems
Osteopal
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 Osteopal
We do not have contact details for Heraeus Medical GmbH yet. Send a request and we will route it to the right person for your country.
Osteopal 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 |
|---|---|---|---|
| plus | — | Not stated | Available |
| V | — | Not stated | Available |
| V | — | MR Safe | Available |
FDA clearances
- 510(k) K241674 December 2024
- 510(k) K153737 April 2016
- 510(k) K050085 September 2005
Procedures that use kyphoplasty systems
Frequently asked questions
What is Osteopal 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 Osteopal?
Osteopal is made by Heraeus Medical GmbH. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Osteopal come in?
The FDA device database does not list sizes for Osteopal. Check the instructions for use or ask a Heraeus Medical GmbH representative.
Is Osteopal MRI safe?
The FDA device database entry for Osteopal does not state its MRI safety status. Check the labeling before MRI.
Is Osteopal FDA cleared?
Osteopal is covered by FDA submissions K153737, K050085, K241674.
How do I contact a Heraeus Medical GmbH sales representative?
Heraeus Medical GmbH has not listed representatives on LA Vascular yet. Visit the Heraeus Medical GmbH 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.