# K193307: HIP7

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jun 2, 2020 after 186 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: 8 generations back to K983831 (1999). 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)
- K122011: Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap, Brainlab AG (2012) Summary page 4.

## Indications for use
HIP7 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 either on a patient’s preoperative image data being processed by Brainlab IGS platforms, or 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 safe and effective, and where a reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT, X-Ray, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures for the Computer Assisted Total Hip Replacement – HIP7 use case include but are not limited to: • Total Joint Replacement • Minimally invasive orthopedic surgery

Source page: https://510kreport.com/device/K193307
Methodology: https://510kreport.com/methodology