# K150741: TSolution One w/ACG surgical System

- Pathway: 510(k) (Traditional)
- Applicant: THINK Surgical, Inc.
- Decided: Oct 22, 2015 after 213 days
- Product code: OJP (Orthopedic Computer Controlled Surgical System)
- 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: 11 generations back to K983831 (1999). 71 ancestors in all.
9 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)
- K140585: CTC Tcat (R)-Tplan (R) Surgical System, Curexo Technology Corporation (2014) Summary page 4.
- K140331: Orthalign Plus System, Orthalign, Inc. (2014) Summary page 4.

## Most influential descendants
- K153647: TSolution One w/ACG+ Surgical System (2016), 8 descendants of its own
- K162195: TSolution One Cup1 Surgical System (2016), 7 descendants of its own
- K170430: TSolution One Surgical System Model 210 (2017), 6 descendants of its own
- K191369: TSolution One Total Knee Application (2019), 5 descendants of its own
- K193135: TSolution One Total Knee Application (2019), 4 descendants of its own

## Indications for use
The TSolution One™ w/ACG Surgical System is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical 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 is used as an alternative to manual planning and broaching/reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach. The TSolution One™ w/ACG Surgical System is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made. The TSolution One™ w/ACG Surgical System 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™ w/ACG Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.

Source page: https://510kreport.com/device/K150741
Methodology: https://510kreport.com/methodology