Neurology · 510(k) · 2024
OTS Hip
Ortoma AB. Cleared by FDA on 11 March 2024 under submission K232140, product code OLO (orthopedic stereotaxic instrument). What FDA's record says, in FDA's words.
Device record · K232140
- Device. OTS HipDEVICE
- Company. Ortoma AB (SE)COMPANY
- Decision. 11 March 2024, 510(k), substantially equivalent (traditional review); received 18 July 2023DECISION
- Panel. NeurologyPANEL
- Product code. OLO, Orthopedic Stereotaxic InstrumentCODE
- Regulation. 21 CFR 882.4560, Class IIREG
- Source. FDA database entry · decision document (15 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.
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform. The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a CT-based model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position. The system is designed for orthopedic surgical procedures including: - Pre-operative planning of Total Hip Arthroplasty (THA) - Intraoperative navigated surgery for THA using a posterior approach
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
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 Ortoma AB, or cleared in 2024. 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.