# K223553: Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Aug 2, 2023 after 250 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: 8 generations back to K983831 (1999). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Brainlab AG (2022) Summary page 4.

## Most influential descendants
- K262257: Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K223553
Methodology: https://510kreport.com/methodology