Sam Brusco10.11.22
OsteoCentric Technologies has gained two new U.S. Food and Drug Administration (FDA) 510(k) clearances: The OstroCentric Pedicle Screw Fastener System featuring proprietary UnifiMI tech, and the Integrity-SI Fusion System with indications in trauma surgery.
Both will be featured at this year’s North American Spine Society (NASS) annual meeting.
Integrating the Mechanical Integration (UnifiMI) method into a pedicle system is an impactful strategy following market disruption of UnifiMI technology in the ortho trauma space. The OsteoCentric Pedicle Screw Fastener System is designed to create stability between the pedicle and implant, limiting construct loosening and enhancing stability.
"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," Eric Brown, founder and CEO of OsteoCentric told the press.
The Integrity-SI Fusion System featuring UnifiMI clearance expands indication to SI trauma and bolster’s the company’s standing in the trauma market.
"The Integrity-SI Fusion System coupled with UnifiMI is designed and optimized to incorporate fusion principles rooted in orthopedic history. These principles include: a biomechanically superior surgical approach, aggressive joint preparation, auto and allograft application, joint compression, and leading construct stability," said Dr. William Cross, an orthopedic surgeon at Mayo Clinic specializing in the treatment of SI-related conditions.
Both will be featured at this year’s North American Spine Society (NASS) annual meeting.
Integrating the Mechanical Integration (UnifiMI) method into a pedicle system is an impactful strategy following market disruption of UnifiMI technology in the ortho trauma space. The OsteoCentric Pedicle Screw Fastener System is designed to create stability between the pedicle and implant, limiting construct loosening and enhancing stability.
"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," Eric Brown, founder and CEO of OsteoCentric told the press.
The Integrity-SI Fusion System featuring UnifiMI clearance expands indication to SI trauma and bolster’s the company’s standing in the trauma market.
"The Integrity-SI Fusion System coupled with UnifiMI is designed and optimized to incorporate fusion principles rooted in orthopedic history. These principles include: a biomechanically superior surgical approach, aggressive joint preparation, auto and allograft application, joint compression, and leading construct stability," said Dr. William Cross, an orthopedic surgeon at Mayo Clinic specializing in the treatment of SI-related conditions.