# K201255: TSolution® One Total Knee Application

- Pathway: 510(k) (Special)
- Applicant: THINK Surgical, Inc.
- Decided: Jun 10, 2020 after 30 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K983831 (1999). 77 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191369: TSolution One Total Knee Application, THINK Surgical, Inc. (2019) Summary page 4.
- K193135: TSolution One Total Knee Application, THINK Surgical, Inc. (2019) Summary page 4.

## Most influential descendants
- K203040: TSolution One Total Knee Application (2020), 2 descendants of its own
- K252037: CUVIS-joint (CJ150) (2026), 0 descendants of its own
- K210668: TSolution One Total Knee Application (2021), 0 descendants of its own

## Indications for use
The TSolution One® Total Knee Application is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA). The TSolution One® Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made. The TSolution One® Total Knee Application is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Total Knee Application facilitates accurate positioning of TKA implants, relative to these alignment axes. The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems: • Zimmer Persona™ Knee System • Corin Unity Knee System • Aesculap Columbus Knee System • DJO Surgical® EMPOWR 3D Knee® System • United U2 Knee System

Source page: https://510kreport.com/device/K201255
Methodology: https://510kreport.com/methodology