OrthoLimited
balloon filling device
OrthoLimited

Balloon Filling Device

Balloon Filling Device — a kyphoplasty device from OrthoLimited, supplied to ISO 13485 standards for hospitals and distributors worldwide.

Brand
OrthoLimited
Manufactured by
OrthoLimited Inc.
Warehouse
EU
Availability
In stock
  • ✓ CE marked
  • ✓ ISO 13485
  • ✓ Warranty included
  • ✓ Worldwide shipping
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Regulatory: For professional surgical use only. Availability and certification vary by country; confirm local regulatory status before purchase or use.

Clinical overview

Product overview

What is balloon kyphoplasty?

Balloon kyphoplasty is a minimally invasive procedure designed to repair vertebral compression fractures (VCF) by reducing and stabilizing fractures. It treats pathological vertebral fractures caused by osteoporosis, cancer or benign lesions.

How Balloon Osteoplasty Works

Creating a space for the balloon

The surgeon will make a pathway into the fractured vertebra using a hollow instrument. A small balloon is then guided through the instrument into the bone.

Inflating the balloon

Once in position, the balloon is slowly inflated to gently raise the collapsed bone into its normal position.

Removing the balloon

When the bone is in the correct position, the surgeon deflates and removes the balloon. This leaves behind a void—or cavity—within the vertebral body.

Filling the vertebral void

To prevent the bone from collapsing again, the void is filled with orthopaedic cement.

Forming the internal cast

Once set, the cement forms a cast inside the vertebral body that stabilizes the bone. To fully secure the bone, the procedure is sometimes performed on both sides of the vertebral body.

The primary benefits of balloon kyphoplasty include:

  • A shorter surgical time; the procedure usually takes about a half hour per spinal level.

  • The kyphoplasty procedure can often be performed with local anesthesia. However, some patients, depending on their general health and severity of the spinal fracture(s) may require general anesthesia.

  • Patients are able to walk and return to their normal activities soon after surgery.

  • Kyphoplasty may be performed in an ambulatory surgery center (ASC), hospital, or outpatient spine surgery center.

  • Most patients are discharged home the same day as their kyphoplasty procedure. An overnight hospital stay may be recommended for some patients depending on many factors, such as coexisting medical problems (eg, cardiovascular risks).

Length of Stay and Recovery

Your doctor will give you specific post-operative instructions, but generally, you will spend about an hour in the recovery room after the procedure. There, a nurse diligently monitors your vital signs, which includes back pain.

Most patients are discharged from the ASC or hospital within 24 hours of their balloon kyphoplasty procedure. At your surgical follow-up appointment, your doctor will assess your recovery progress to determine if you should limit certain activities (eg, lifting). Many patients report significant improvements in pain, mobility and the ability to perform daily tasks—so you may not need to make any adjustments to your physical activity level.

Key features

Why clinicians choose this device

01

A shorter surgical time; the procedure usually takes about a half hour per spinal level.

02

The kyphoplasty procedure can often be performed with local anesthesia. However, some patients, depending on their general health and severity of the spinal fracture(s) may require general anesthesia.

03

Patients are able to walk and return to their normal activities soon after surgery.

04

Kyphoplasty may be performed in an ambulatory surgery center (ASC), hospital, or outpatient spine surgery center.

05

Most patients are discharged home the same day as their kyphoplasty procedure. An overnight hospital stay may be recommended for some patients depending on many factors, such as coexisting medical problems (eg, cardiovascular risks).

Documents & downloads

Regulatory paperwork & manuals

Pre-cleared documentation for this device. Full tender-pack originals are available on request.

Documents & downloads

Regulatory paperwork & manuals

This device's IFU, CE Declaration of Conformity, ISO 13485 certificate and (where applicable) FDA 510(k) clearance ship with the order. Reach out below for the pack ahead of purchase.

Get in touch

Need configuration help, certificates, or volume pricing?

Our clinical sales team will scope quantities, voltage, accessories and regulatory paperwork — usually within one business day.

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