# K122011: Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Nov 15, 2012 after 129 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K983831 (1999). 35 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 41 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.
- K063028: Vectorvision Hip SR, Brainlab AG (2006) Summary page 3.
- K110021: Dash Hip, Brainlab AG (2011) Summary page 1.
- K102990: Brainlab Knee, Brainlab AG (2011) Summary page 1.
- K110204: Brainlab Trauma, Brainlab AG (2011) Summary page 3.

## Most influential descendants
- K181449: Ortoma Treatment Solution - OTS (2018), 3 descendants of its own
- K232140: OTS Hip (2024), 2 descendants of its own
- K250086: OTS Hip (2025), 1 descendant of its own
- K261852: OTS Hip (2026), 0 descendants of its own
- K193307: HIP7 (2020), 0 descendants of its own

## Recalls of this device
- Jan 16, 2015 · Class II · Z-1215-2015: The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.

## Indications for use
Total Hip Replacement (THR) procedures The Brainlab Hip system 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 the skull, 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 include but are not limited to: Total Joint Replacement Minimally invasive orthopedic surgery Tumor resection and bone/joint reconstruction Surface Replacement (SR) procedures The Brainlab Hip system is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on Brainlab IGS platforms. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by 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 appropriate and where a reference to a rigid anatomical structure, such as the skull, 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 in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: Partial/hemi-hip resurfacing.

Source page: https://510kreport.com/device/K122011
Methodology: https://510kreport.com/methodology