# K063028: Vectorvision Hip SR

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Dec 12, 2006 after 71 days
- Product code: HAW (Neurological 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: 3 generations back to K010612 (2001). 5 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040368: Vectorvision Hip 3.0, Brainlab AG (2004) Summary page 1.
- K042513: Vectorvision Osteotomy, Brainlab AG (2005) Summary page 1.

## Most influential descendants
- K122011: Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap (2012), 5 descendants of its own
- K181449: Ortoma Treatment Solution - OTS (2018), 3 descendants of its own
- K232140: OTS Hip (2024), 2 descendants of its own
- K071929: Navitrack System- Partial Hip Resurfacing Universal (2007), 2 descendants of its own
- K250086: OTS Hip (2025), 1 descendant of its own

## Indications for use
BrainLAB's VectorVision® hip SR 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 a VectorVision® navigation station. 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/K063028
Methodology: https://510kreport.com/methodology