The US Food and Drug Administration (FDA) has issued 510(k) clearance for Think Surgical’s Tmini miniature robotic system to be used with Zimmer Biomet’s Persona knee system.
This clearance marks a significant achievement for Think Surgical, as it now offers a robotic system that supports an exclusive implant option with the Persona Knee System and an open platform compatible with various manufacturers’ implants for total knee arthroplasty.
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Tmini is a small, handheld device that assists in knee replacement surgery.
Capable of compensating for a hand movement for the surgeon, the Tmini locates bone pins using a CT-based three-dimensional surgical plan. Cutting guides are later on connected to the bone pins for bone resection precisely.
Think Surgical now serves as the sole provider of a robotic system that caters to two different customer preferences: those who desire an open platform with a selection of implant options and individuals who prefer an exclusive system with the Persona knee system.
The company’s strategy to market the Tmini System aligns with the needs of distinct customer segments. One segment favours the flexibility of choosing from multiple implant manufacturers while the other prefers the exclusivity of the platform with Persona.
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By GlobalDataThink surgical CEO Stuart Simpson said: “Tmini addresses surgeon demand for ergonomic, wireless, handheld robotic systems and we believe this will accelerate the adoption of robotics in knee procedures, particularly in the out-patient setting.”
Recently, Think Surgical secured 510(k) clearance for the use of its Tmini miniature robotic system with Medacta’s SpheriKA knee systems.
