# K060468: Vectorvision Hip

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Mar 20, 2006 after 25 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: 4 generations back to K010612 (2001). 9 ancestors in all.
154 later devices descend from it; 3 cite it directly.
0 of 164 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.
- K052213: Navigation SW Hip 3.1 on CI, Brainlab AG (2005) Summary page 1.

## Most influential descendants
- K070731: Pigalileo Total Hip Replacement (THR) System (2007), 81 descendants of its own
- K080875: Pigalileo 4TH Generation System (2008), 79 descendants of its own
- K090420: Smith & Nephew Pigalileo Screw Targeting System V 1.0 (2009), 78 descendants of its own
- K092497: Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 (2009), 77 descendants of its own
- K100107: Smith & Nephew Sureshot Distal Targeting System V2.0 (2010), 75 descendants of its own

## Indications for use
BrainLAB VectorVision hip is intended to be an intraoperative image guided localization system. 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 a VectorVision workstation 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 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, MR based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprothesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: Total Joint Replacement (TJR) Revision surgery of TJR Tumor resection and bone/joint reconstruction

Source page: https://510kreport.com/device/K060468
Methodology: https://510kreport.com/methodology