# K110021: Dash Hip

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Oct 18, 2011 after 288 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: 6 generations back to K010612 (2001). 15 ancestors in all.
47 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083483: Brainlab Hip Unlimited, CI Hip Unlimited, Brainlab AG (2009) Summary page 1.
- K014256: Kolibri Igs Systems, Brainlab AG (2002)

## Most influential descendants
- K140331: Orthalign Plus System (2014), 29 descendants of its own
- K153237: OrthAlign Plus System (2016), 18 descendants of its own
- K162962: OrthAlign Plus System (2017), 15 descendants of its own
- K171780: OrthAlign Plus System (2017), 12 descendants of its own
- K133759: Intellijoint Hip (2014), 10 descendants of its own

## Indications for use
DASH hip is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be sate and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies. Example orthopedic surgical procedures include but are not limited to: Total Hip Replacement (THR) Revision surgery of THR Minimally Invasive THR Surgery

Source page: https://510kreport.com/device/K110021
Methodology: https://510kreport.com/methodology