THINK Surgical has received the US Food and Drug Administration (FDA) 510(k) clearance for the expanded use of the TMINI miniature robotic system.
The TMINI system is now approved for use with the MOBIO Total Knee System from New Jersey-based b-ONE Ortho. This FDA 510(k) clearance follows a collaboration agreement between THINK Surgical and b-ONE Ortho.
The MOBIO Total Knee System is now part of THINK Surgical’s ID-HUB. This proprietary implant database supports the TMINI robotic system’s open platform in the US.
b-ONE Ortho general manager Jim Duncan said: “We are very enthusiastic about receiving this clearance for use with the THINK Surgical TMINI System platform, which not only enhances our MOBIO Total Knee System portfolio in offering our customers a robotic assisted technology solution, but it also provides b-ONE greater market penetrating strategic options and solutions.
“We look forward to this continued partnership with THINK Surgical offering a proven total knee design that can provide a smooth transition for many surgeons across the US.”
The latest clearance closely follows FDA approval for the use of Maxx Orthopedics’ Freedom Total Knee, Freedom Titan Knee, and Freedom Primary PCK Systems implants with the TMINI system.
The robotic system was also cleared for use with the LinkSymphoKnee (LSK) implants from Waldemar Link.
The TMINI Miniature Robotic System originally received FDA 510(k) clearance in May 2023.
In July 2024, the FDA cleared Think Surgical’s TMINI 1.1 miniature surgical robot software.
THINK Surgical president and CEO Stuart Simpson said: “THINK Surgical is excited to add the MOBIO Total Knee System to the TMINI System.
“The open platform version of TMINI is now available with eight different knee designs from eight separate orthopaedic companies offering surgeons the choice of single-radius, anatomic, and guided motion knees on a single robotic platform.”
