# K072629: Digimatch Robodoc Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Surgical Systems, Inc.
- Decided: Aug 6, 2008 after 324 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: 6 generations back to K930667 (1994). 35 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052851: Voyager Linux with Tactile Guidance System (TGS), Mako Surgical Corp. (2005) Summary page 1.
- K991081: Frameless Neuromate, Integrated Surgical Systems, Inc. (1999) Summary page 1.
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000, Intuitive Surgical, Inc. (2004) Summary page 1.

## Most influential descendants
- K140585: CTC Tcat (R)-Tplan (R) Surgical System (2014), 10 descendants of its own
- 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

## Indications for use
The DigiMatchTM ROBODOC® 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 intra-operative 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 DigiMatch ROBODOC 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/K072629
Methodology: https://510kreport.com/methodology