# K220774: RobPath® Total Hip Application

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Lancet Robotics Co., Ltd.
- Decided: Dec 9, 2022 after 268 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: 16 generations back to K905070 (1991). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193128: Mako Total Hip Application, Mako Surgical Corp. (2020) Summary page 4.

## Indications for use
The RobPath® Total Hip Application is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RobPath® Total Hip Application is indicated for use in a surgical hip procedure in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: • Total Hip Arthroplasty (THA)

Source page: https://510kreport.com/device/K220774
Methodology: https://510kreport.com/methodology