Pharma To Date

Think Surgical has achieved a notable milestone in the field of orthopedic robotics with the recent FDA clearances for its handheld knee replacement robot, TMINI. This development represents a significant advancement in the precision and efficiency of knee replacement procedures.

The TMINI platform, which first received FDA approval in May 2023, is designed to enhance the accuracy of knee surgeries through a wireless, handheld system. By utilizing a three-dimensional model generated from a CT scan, the device assists surgeons in the precise placement of bone pins and cutting guides. This innovative approach aims to improve surgical outcomes and reduce the risk of complications associated with traditional methods.

In July 2024, Think Surgical received an updated 510(k) clearance for version 1.1 of the TMINI system. This upgrade introduces features that refine the positioning and soft-tissue balance of the replacement joint, further enhancing the robot's capabilities and its impact on surgical precision.

The recent clearances in August and September extend the platform’s versatility by supporting two distinct tracks of development. The open platform version, which has been integrated with Medacta International’s GMK Sphere and SpheriKA knee systems, allows for compatibility with a range of hardware options. Meanwhile, the exclusive version, customized for Zimmer Biomet’s Persona knee, caters to surgeons who prefer a dedicated system aligned with a single implant brand.

This dual approach addresses varying preferences within the orthopedic community. The open platform offers flexibility, accommodating different implant systems, while the exclusive version provides a tailored solution for those committed to a specific brand. Think Surgical estimates that its device can support approximately 40% of the total knee implants available on the market, reflecting its broad applicability and potential for widespread adoption.

The significance of these advancements lies in their potential to accelerate the adoption of robotic-assisted knee surgeries, particularly in outpatient settings. By offering both an open and exclusive platform, Think Surgical is positioning itself to meet diverse needs within the orthopedic field, ultimately contributing to improved patient outcomes and advancing the practice of knee replacement surgery.