14 Oct OsteoCentric Technologies Receives Two New 510k’s Prior to The North American Spine Society’s Annual Meeting
AUSTIN, Texas, Oct. 11, 2022 /PRNewswire/ — OsteoCentric Technologies, a privately held medical device company pioneering Mechanical Integration technology (UnifiMI™) for orthopedic and dental implants, has been issued two new FDA 510k clearances. The OsteoCentric Pedicle Screw Fastener System™ will feature UnifiMI technology, and the Integrity-SI Fusion System™ now includes indications in trauma surgery. Both systems will be featured at this month’s 37th Annual North American Spine Society Meeting in Chicago, IL, October 12-14th at Booth #2227.
Due to the importance of acute fixation and multi-axis stability in spine surgery, integrating the Mechanical Integration (UnifiMI) method into a pedicle system is an impactful strategic pathway following the market disruption of UnifiMI technology in the orthopedic trauma space. The pedicle market is now approaching $4.7B (WW)1 with patient demographics and surgical volume both favorably affecting growth. Utilizing UnifiMI, 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,” says Eric Brown, Founder, and CEO of the company.
The Integrity-SI Fusion System featuring UnifiMI clearance expands the System indications for use in SI trauma and bolsters OsteoCentric’s growing footprint in the $9.2B (WW)1 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,” says Dr. William Cross, an orthopedic surgeon at Mayo Clinic specializing in the treatment of SI-related conditions.
In parallel to these new clearances, OnPoint Advisors (Dallas, Texas) is leading a growth capital fund to fund sales and inventory across the orthopedic and dental market verticals.
About OsteoCentric Technologies
As a technology company focused on addressing implant instability at the bone-implant interface, OsteoCentric is guided by input from leading surgeons. The company was founded in 2015 and has offices in Logan, Utah, and Austin, Texas.
| 1 – Future Market Insights, Inc. (FMI). “Orthopedic Trauma Devices Market Report.” July 2022. https://www.futuremarketinsights.com/reports/orthopedic-trauma-devices-market |
SOURCE OsteoCentric Technologies, PR Newswire, October 11 2022.
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