# K262257: Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab SE
- Decided: Sep 30, 2026 after 90 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: 9 generations back to K983831 (1999). 34 ancestors in all.
No later device cites it as a predicate yet.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223553: Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine, Brainlab AG (2023) Summary page 5.
- K221618: Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System, Brainlab AG (2022) Summary page 5.

## Indications for use
Spine Planning: Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and planning of spinal implants like screws and rods. The device is indicated for adult patients. Spine & Trauma Navigation: Spine & Trauma Navigation 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 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, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image databased model of the anatomy. Alignment System Spine: As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.

Source page: https://510kreport.com/device/K262257
Methodology: https://510kreport.com/methodology