# K083310: Spine & Trauma Ict

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Apr 1, 2009 after 142 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 K983831 (1999). 10 ancestors in all.
40 later devices descend from it; 3 cite it directly.
1 of 51 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070106: VV Fluoro 3D, Brainlab AG (2007) Summary page 1.

## Most influential descendants
- K183605: Spine & Trauma Navigation (2019), 25 descendants of its own
- K212245: Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning (2022), 15 descendants of its own
- K130887: S4C Navigation Instruments (2013), 13 descendants of its own
- K181890: Brainlab Compatible K2M Navigation Instruments (2018), 11 descendants of its own
- K202320: CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System (2020), 9 descendants of its own

## Indications for use
BrainLAB Spine & Trauma iCT is intended as 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 on a patient's preoperative or intraoperative 3D image data. Spine & Trauma iCT enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools. 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, the pelvis, a long bone or vertebra can be identified relative to the acquired CT image.

Source page: https://510kreport.com/device/K083310
Methodology: https://510kreport.com/methodology