# K183605: Spine & Trauma Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Aug 29, 2019 after 246 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K983831 (1999). 11 ancestors in all.
25 later devices descend from it; 6 cite it directly.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083310: Spine & Trauma Ict, Brainlab AG (2009) Summary page 4.

## Most influential descendants
- 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
- 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
- K201661: Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set (2020), 7 descendants of its own
- 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

## Recalls of this device
- Aug 20, 2020 · Class II · Z-2925-2020: Holding force of the Positioning Arm can be reduced by prolonged non-use.
- Jul 16, 2020 · Class II · Z-2793-2020: Incorrect manufacturer calibration
- Jul 16, 2020 · Class II · Z-2792-2020: Incorrect manufacturer calibration

## Indications for use
Spine & Trauma 3D 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 2D or 3D image data. Spine & Trauma 3D 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 image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

Source page: https://510kreport.com/device/K183605
Methodology: https://510kreport.com/methodology