# K181449: Ortoma Treatment Solution - OTS

- Pathway: 510(k) (Traditional)
- Applicant: Ortoma AB
- Decided: Sep 19, 2018 after 110 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). 36 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122011: Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap, Brainlab AG (2012) Summary page 4.

## Most influential descendants
- K232140: OTS Hip (2024), 2 descendants of its own
- K250086: OTS Hip (2025), 1 descendant of its own
- K261852: OTS Hip (2026), 0 descendants of its own

## Indications for use
The Ortoma Treatment Solution system is intended to be an intraoperative image-guided localization system to enable navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space either on a patient's preoperative image data being processed by OTS platform, or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for hip surgical procedures, in which the use of navigated surgery is considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT-based model of the anatomy. The system aids the surgeon to accurately navigate a hip prosthesis to the preoperatively planned position. Example orthopedic surgical procedures include but are not limited to: Total Hip Arthroplasty (THA) using posterior approach. Preoperative planning and intraoperative navigated surgery for joint replacement with Stryker Exeter X3 Rimfit cups.

Source page: https://510kreport.com/device/K181449
Methodology: https://510kreport.com/methodology