FDA Clears Mechanical Integration Pedicle Screw System

A new pedicle screw system has received FDA 510(k) clearance.

The thoracolumbosacral pedicle screw system, brand named OsteoCentric Spine MIS Pedicle Fastener System and manufactured by OsteoCentric Technologies, is, of course, “intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.”

That’s directly from the FDA clearance document.

More specifically, the pedicle screws are designed for “noncervical pedicle fixation for the following indications:

1. degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies);
2. spondylolisthesis;
3. trauma (i.e., fracture or dislocation);
4. spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or thoracolumbosacral pedicle screw system lordosis);
5. tumor, pseudoarthrosis; and
6. failed previous fusion in skeletally mature patients.” When the system is used in a posterior percutaneous approach with MIS instrumentation, the system is intended for noncervical pedicle fixation and non-pedicle fixation for the same indications listed above.

The thoracolumbosacral pedicle screw system is substantially similar to the thoracolumbosacral pedicle screw system by Altus Partners, LLC.

According to OsteoCentric, the OsteoCentric Pedicle Screw Fastener System™ will feature UnifiMI technology. In the press release, OsteoCentric Founder and CEO Eric Brown explained, “The UnifiMI Pedicle Fastener will be the only system on the market leveraging Mechanical Integration technology to address implant instability at the bone-implant interface.”

Along with the FDA 510(k) clearance of its pedicle screw system, OsteoCentric is gaining additional momentum in the market with the FDA 510(k) clearance of its sacroiliac joint system and with a growth capital fund led by OnPoint Advisors. The fund is going to support mechanical integration in both orthopedics and dental.