# K232140: OTS Hip

- Pathway: 510(k) (Traditional)
- Applicant: Ortoma AB
- Decided: Mar 11, 2024 after 237 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K983831 (1999). 37 ancestors in all.
2 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)
- K181449: Ortoma Treatment Solution - OTS, Ortoma AB (2018) Summary page 5.

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

## Recalls of this device
- Jul 28, 2025 · Class II · Z-2615-2025: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

## Indications for use
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

Source page: https://510kreport.com/device/K232140
Methodology: https://510kreport.com/methodology