# K140585: CTC Tcat (R)-Tplan (R) Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Curexo Technology Corporation
- Decided: Aug 18, 2014 after 164 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: 7 generations back to K930667 (1994). 36 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072629: Digimatch Robodoc Surgical System, Integrated Surgical Systems, Inc. (2008) Summary page 4.

## Most influential descendants
- K150741: TSolution One w/ACG surgical System (2015), 9 descendants of its own
- 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

## Indications for use
The TCAT™/TPLAN™ Surgical System is intended for use as a device which 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 techniques for femoral canal preparation in primary total hip arthroplasty (THA). The TCAT™/TPLAN™Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

Source page: https://510kreport.com/device/K140585
Methodology: https://510kreport.com/methodology