# K110204: Brainlab Trauma

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Aug 5, 2011 after 193 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: 6 generations back to K010612 (2001). 18 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062358: Modification to Vectorvision Trauma, Brainlab AG (2007) Summary page 1.
- K042721: Kolibri Spine, Brainlab AG (2005) Summary page 4.
- K083483: Brainlab Hip Unlimited, CI Hip Unlimited, Brainlab AG (2009) Summary page 1.

## Most influential descendants
- K130887: S4C Navigation Instruments (2013), 13 descendants of its own
- K181890: Brainlab Compatible K2M Navigation Instruments (2018), 11 descendants of its own
- K192911: Brainlab Compatible K2M Navigation Instruments (2019), 9 descendants of its own
- K203205: Navigated Spine Instruments (2021), 8 descendants of its own
- K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (2024), 7 descendants of its own

## Indications for use
Brainlab trauma is intended to be a pre- and 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 on a patient's pre- or intraoperative image data being processed by a VectorVision workstation. 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 bone structure like tubular bones, pelvic, calcaneus and talus, scapula, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy. In addition to the image guided navigation, Brainlab trauma also enables image-free navigation of trajectories for trauma procedures. Example procedures include but are not limited to: * Spinal procedures and spinal implant procedures such as pedicle screw placement. * Pelvis and acetabular fracture treatment such as screw placement or hlo-sacral screw fixation. * Fracture treatment procedures such as intramnedullary nailing or plating or screwing, or external fixation procedures in the tubular bones. * Retrograde drilling of osteochondral lesions

Source page: https://510kreport.com/device/K110204
Methodology: https://510kreport.com/methodology