# K140038: Digimatch Orthodoc Robodoc Encore Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Curexo Technology Corporation
- Decided: May 27, 2014 after 140 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.
No later device cites it as a predicate yet.
0 of 37 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 1.

## Indications for use
The DigiMatchTM ROBODOC®/ORTHODOC® Encore 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 aribroplasty (THA). The DigiMatchTM ROBODOC®ORTHODOC® Encore 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/K140038
Methodology: https://510kreport.com/methodology