# 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

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 13, 2022 after 268 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: 7 generations back to K983831 (1999). 17 ancestors in all.
15 later devices descend from it; 5 cite it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183605: Spine & Trauma Navigation, Brainlab AG (2019) Summary page 4.
- K170011: StealthStation S8 Spine Software v1.0.0, Medtronic Navigation (2017) Summary page 4.

## Most influential descendants
- K221618: Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System (2022), 6 descendants of its own
- K212756: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set (2022), 5 descendants of its own
- K223108: TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) (2023), 4 descendants of its own
- K242933: SPINEART Navigation Instrument System (2025), 2 descendants of its own
- K233254: TELIGEN System Navigation Ready Instruments (2024), 2 descendants of its own

## Indications for use
Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable open and 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 2D or 3D image data. Spine & Trauma Navigation System 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 and interbody device planning and navigation with surgical instruments. 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 image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. Spine Planning is intended for pre- and intraoperative planning of open- and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods.

Source page: https://510kreport.com/device/K212245
Methodology: https://510kreport.com/methodology