Neurology · 510(k) · 2023
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Brainlab AG. Cleared by FDA on 2 August 2023 under submission K223553, product code OLO (orthopedic stereotaxic instrument). What FDA's record says, in FDA's words.
Device record · K223553
- Device. Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineDEVICE
- Company. Brainlab AG (DE)COMPANY
- Decision. 2 August 2023, 510(k), substantially equivalent (traditional review); received 25 November 2022DECISION
- Panel. NeurologyPANEL
- Product code. OLO, Orthopedic Stereotaxic InstrumentCODE
- Regulation. 21 CFR 882.4560, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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. K223553, 2/5 2 DEVICE DESCRIPTION The Spine Planning software allows the user to plan spinal surgery pre -operatively or intra-operatively. The software is able to display 2D X- Ray images and 3D datasets (e.g. CT or MR scans). The software consists of features for automated labelling of vertebrae and proposals for screw and rod implants, proposals for measurement of spinal parameters. The device can be used in combination with spinal navigation software during surgery, where pre - planned or intra -operatively created information can be displayed, or solely as a pre -operative tool to prepare the surgery. AI/ML algorithms are used in Spine Planning for • Detection of landmarks on 2D images for vertebrae labeling and measurement and • Vertebra detection on Digitally Reconstructed Radiograph (DRR) images of 3D datasets for atlas registration (labeling of the vertebra). The AI/ML algorithm is a Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and verification of the algorithm. 3 SUBSTANTIAL EQUIVALENCE The Subject Device has similar intended use and […]
The product code's definition, from FDA's classification record. Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, MRI, radiographs (X-ray)
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 20,865 reports filed against devices carrying product code OLO. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · REAMER HANDLE OFFSET · MAKO Surgical Corp. · report 3005985723-2026-00510
Screws loose Case Type / Application: THA 5.0.
30 September 2026 · Malfunction · Stealth AXiS · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01387
Medtronic received information regarding a navigation device being used intra-operatively during a sacroiliac and thoracolumbar procedure. It was reported that the trajectories could not be reached. All were marked as red. The site attempted to reposition to R-L5 and the trajectory guide ran into the patient reference frame clamped on L4. Surgeon grabbed the arm to stop it using the force sensor. Performed anatomy checks with probe to confirm accuracy. Accuracy was confirmed and the procedure […]
30 September 2026 · Malfunction · NAVLOCK · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01388
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure. It was reported that the probes tip broke. Delay and patient impact were not reported.
30 September 2026 · Injury · 5.5mm Tap, Navigation · Orthopediatrics · report 3006460162-2026-00057
29 September 2026 · Malfunction · REAMER HANDLE OFFSET · MAKO Surgical Corp. · report 3005985723-2026-00503
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OLO, in Neurology, from Brainlab AG, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.