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OTS Hip

Ortoma AB

Country / Region:Sweden (SE)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Sweden (SE)

Product code

OLO
21 CFR 882.4560

Predicate devices

1

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K232140
Device name
OTS Hip
Company
Ortoma AB
Country / Region
Sweden(SE)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-07-18
Decision date
2024-03-11
Submission type
Traditional
Technology type
Image Guided Surgery(AI inferred)
Clinical applications
Navigation SystemOther
Primary application
Navigation System
Classification source
AI classified

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. 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. Example orthopedic surgical procedures include but are not limited to: • Pre-operative planning and of Total Hip Arthroplasty (THA) • Intraoperative navigated surgery for THA using a posterior approach. • Total Hip Arthroplasty (THA) using posterior approach. • Preoperative planning and intraoperative navigated surgery for joint replacement with Stryker Exeter X3 Rimfit cups. User Population: Orthopedic surgeon. Anatomical Site: Hip. Where Used: Office of user and Operating room.

Intended 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) and Intraoperative navigated surgery for THA using a posterior approach.

Device Description

OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery. OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system. The system uses medical imaging data in DICOM format that is loaded into the system for access in the software that are part of the system. OTS Hip software consists of OTS Hip Plan (OHP), which is a 3D preoperative planning software, and OTS Hip Guide (OHG) that provides intraoperative real-time navigation for the guidance of surgical tools and prosthetic components in relation to the preoperatively determined goal positions. OHP enables the orthopedic surgeon to prepare surgery by analyzing the patient anatomy in a 3D environment based on medical imaging data. OHG imports the result from the preceding planning stage, a released plan, with the 3D model and planned data, from the database of the OTS system. In addition, OHG monitors the real-time information of the position of instruments and prosthetic components in a 3D environment by means of medical imaging data. The components of the OHG device include a camera and computer stand with an electrical system to which a camera and a medical panel PC are attached, a footswitch, a keyboard, Tracers (passive markers), adapters that hold the Tracers and can be mounted to compatible surgical instruments and that are used for calibration, and tools and instruments that are used during surgery. The OTS is compatible with various Depuy Synthes components.

Summary parsed at:2026-06-19 05:27:30 UTC

Predicate devices

1

K232140 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K232140 as a predicate