# K083483: Brainlab Hip Unlimited, CI Hip Unlimited

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 8, 2009 after 135 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: 5 generations back to K010612 (2001). 14 ancestors in all.
70 later devices descend from it; 3 cite it directly.
0 of 85 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.
- K060468: Vectorvision Hip, Brainlab AG (2006) Summary page 1.
- K060727: Vectorvision Hip, Brainlab AG (2006) Summary page 1.
- K072716: Vector Vision Hip, Brainlab AG (2007) Summary page 1.

## Most influential descendants
- K110021: Dash Hip (2011), 47 descendants of its own
- K140331: Orthalign Plus System (2014), 29 descendants of its own
- K110204: Brainlab Trauma (2011), 27 descendants of its own
- K153237: OrthAlign Plus System (2016), 18 descendants of its own
- K162962: OrthAlign Plus System (2017), 15 descendants of its own

## Indications for use
BrainLAB hip unlimited 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 a VectorVision or a CiTM 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 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, 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 Minimally Invasive Orthopedic Surgery Tumor resection and bone/joint reconstruction

Source page: https://510kreport.com/device/K083483
Methodology: https://510kreport.com/methodology