The company’s TMINI miniature robotic system. Credit: THINK Surgical / PRNewswire.

THINK Surgical has announced that it has secured US Food and Drug Administration (FDA) 510(k) clearance for the use of its Tmini Miniature Robotic System with Medacta’s SpheriKA Knee Systems.

Tmini is a small, handheld surgical implant device that assists in knee replacement surgery. Capable of compensating for a surgeon’s hand movement, it locates bone pins using a CT-based three-dimensional surgical plan. Cutting guides are then connected to the bone pins for precise bone resection.

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The 510(k) clearance means that the implant modules for Medacta’s SpheriKA Knee Systems will be added to THINK Surgical’s ID-HUB, a proprietary data bank for collaborators to use the open platform version of its TMINI System. The company received an initial 510(k) clearance for use with the Enovis EMPOWR Knee System in July 2023.

“Medacta’s commitment to innovation aligns well with THINK Surgical’s dedication to innovation in robotics,” said Stuart Simpson, president, and chief executive officer of THINK Surgical.

“We are excited to partner with Medacta in the USA to offer customers greater choice in patient treatment options.”

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To add further implant modules to ID-HUB, THINK Surgical received a special 510(k) clearance in October 2023 for use with three additional implant manufacturers’ modules.

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In July 2024, the FDA also granted 510(k) clearance for THINK Surgical’s TMINI 1.1 software update, which supports the company’s TMINI PRO workflow for data capture and real-time feedback to allow surgeons to make positional adjustments to help fine-tune implant positioning and stability.

According to GlobalData’s Market Size & Growth Database, the overall robotic surgery systems market was valued at around $2.8bn last year and is forecast to reach a valuation of almost $8.2bn by 2033. The specific orthopaedic robotic systems market was valued at around $371m in 2023 and is forecast to reach a valuation of around $1.1bn by 2033.

Elsewhere in robotics, Microbot recently advanced its Liberty robotic system to the next phase of remote telesurgery evaluation while Medical Microinstruments recently announced the completion of a preclinical study evaluating its surgical robot in neurosurgical procedures.