THINK Surgical, Inc. · Class II · Cleared Oct 10, 2025
| K-number | K252544 |
| Device name | TMINI Miniature Robotic System |
| Applicant | THINK Surgical, Inc. |
| Product code | OLO |
| Device class | Class II |
| Decision date | Oct 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The TMINI Miniature Robotic System is a stereotaxic instrumentation system that assists surgeons in total knee replacement (TKA) surgery by providing software-defined spatial boundaries and reference information for accurate placement of knee implant components. It uses preoperative CT scans to create 3D bone models, allows surgeons to plan implant placement, and uses a hand-held robotic tool guided by optical tracking to position bone pins and cutting guides during surgery.
The device consists of three primary components: a preoperative planning workstation (TPLAN), an optical tracking navigation console (TNav), and a robotically controlled hand-held tool (TMINI Robot). It uses six-camera overhead tracking with wide-angle field of view, optically tracked bone marker arrays for registration, and articulates in two degrees-of-freedom to place bone pins in a planar manner. The key modification in this submission involves changes to the method of generation, verification, and validation of new implant modules, with no changes to the planning software, navigation system, or robotic positioning device.
ISO 14971:2019 (risk management), ISO 10993 (biocompatibility requirements). The submission references performance testing protocols for cutting accuracy, pin and block placement accuracy, gap balance accuracy, user needs validation, usability testing, system software testing, and implant module generation and verification.
The TMINI System (AIM 3.0) is substantially equivalent to its predicate (K250877) because it has the same intended use, indications for use, technological characteristics, design, and materials. The modifications made—changes to implant module generation and verification methods—do not alter the intended use, design principles, or operational characteristics. Design verification and validation testing demonstrated all acceptance criteria were met, no new clinical hazards were identified, and risk analysis showed no change in the overall risk profile compared to the predicate device.
View the full FDA submission: accessdata.fda.gov