Total Joint Replacement for the Lumbar Spine

An alternative to spinal fusion for leg and back pain.

US Patients

We anticipate beginning US patient enrollment in 2021 pending IDE approval.

Patients Outside of the US

The BalancedBack Total Joint Replacement is available under clinical protocol at several sites around the world. 

The Technology

The BalancedBack procedure is the first “total” joint replacement for the lumbar spine. It is a motion-sparing alternative to lumbar spinal fusion, potentially proving a more effective treatment of debilitating leg and/or back pain.  The device replaces the function of the disc and facet joints using a posterior approach, eliminating multiple pain generators while correcting posture and preserving segmental motion. BalancedBack patients can dyanmically adapt their lumbar lordosis and pelvic angle to activities of daily living: stand, sit and slump sit without altering natural biomechanics of the spine.

Data Driven

We are a data driven team. Patients treated with BalancedBack outside of the United States have been tracked in our data registry through REDCap.   A total of 89 BalancedBack Total Joint Replacement procedures have been completed at a total of 133 spinal levels in 3 clinical studies (n=7, n=12, n=70), with up to 13-year follow-up on some of the earliest cases. 

BalancedBack total joint replacements have been performed from L1/L2 to L5/S1, including single-level, two-level, and three-level procedures.  The device has been used in primary cases and adjacent to prior fusions as a revision strategy.   The results of these pilot studies are encouraging and suggest a reasonable expectation this device could provide for more effective treatment relative to the current standard of care with a meaningful clinical improvement in function (disability), leg pain, and back pain in contrast to the current standard of care.

Patient Stories

Following is a sample of BalancedBack Total Joint Replacement patient experiences obtained from multiple OUS pilot clinical studies performed to date.

Note:  This is not a complete list of patient experiences.  Lumbar total joint replacement is not suitable for all patients and there are risks associated with total joint replacement.  As such patient experience may differ from the samples provided. 

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

BalancedBack
BalancedBack