United States Patients

BalancedBack is entering the IDE cycle and expects to begin enrollment for this pivotal trial in 2021 pending IDE approval.

Updates on the US IDE status and centers participating in the trial will be made on this page.

Indications for Use

The BalancedBack Total Joint Replacement is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment in the lumbar spine in skeletally mature patients due to symptomatic lumbar degeneration with or without spinal stenosis.

Lumbar degeneration includes:

  • leg pain or neurologic symptoms with or without back pain due to reoccurring herniated nucleus pulposus,
  • ligamentum flavum hypertrophy,
  • facet degeneration,
  • osteophyte formation,
  • disc degeneration, and/or
  • annular degeneration often causing spinal stenosis (radiculopathy, nerve root compression absent neurologic deficit, radiculitis, or neurogenic claudication).

Prior to receiving the BalancedBack Total Joint Replacement, the diagnosis must be confirmed by radiographic imaging (CT, MRI, Xrays), with no more than a Grade 1 spondylolisthesis at the involved level. Patients must have also exhausted conservative (nonoperative) treatment for at least 3 months (opioid use, physical therapy, invasive cortisone anti-inflammatory medications) or be deemed to have a neurologic emergency or intractable pain.

 

About 3Spine

3Spine is a new kind of healthcare company that vertically integrates the development, clinical research, and delivery of novel healthcare technology.  The BalancedBack Total Joint Replacement is the technology platform developed by 3Spine as an alternative to fusion for the lumbar spine.

3Spine SEZC

Cayman Enterprise City

The Strathvale House, 4th floor

90 N Church Street

George Town, Grand Cayman

Cayman Islands

1-345-232-0690

3Spine Management Co. Inc

46 Railroad Ave

Unit 204

Duxbury, MA 02332

1-781-291-8040

US Regulatory Status

CAUTION: Investigational Device. Limited by United States law to investigational use.

The BalancedBack Total Joint Replacement is not available in the United States. The information within BalancedBack.com
is not intended as a substitute for medical professional help or advice. Statements made on this site are not to be
interpreted as a guarantee.

Cayman REGULATORY STATUS

The BalancedBack Total Joint Replacement is undergoing clinical trial in the Cayman Islands in compliance with section 9
of the 2018 Health Practice Regulations.

South africa REGULATORY STATUS

The BalancedBack Total Joint Replacement is a Class D device in South Africa per Rule 8. This device is available for
investigational use only per Schedule 16 of the Department of Health Regulation No. 1515. The BalancedBack Total Joint
Replacement is for professional use only.

To learn more about Breakthrough Designation

https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

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