Manufacturer
Ortoma ABOTS Hip
Country / Region:Sweden (SE)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250086
- 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
- 2025-01-13
- Decision date
- 2025-05-16
- Submission type
- Traditional
- Technology type
- Image Guided Surgery(AI inferred)
- Clinical applications
- Navigation SystemOther
- Primary application
- Navigation System
- Classification source
- AI classified
Intended Use
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT and X-Ray 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 system generated 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.
Device Description
OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery. The OTS Hip device is a modified device from the company's previously cleared OTS Hip (K232140). 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 is a software for preoperative planning prior to a THA (Total Hip Arthroplasty) surgery. 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 Hip is compatible with the following components: - PINN GB OFFSET GRATER HANDLE, DePuy Synthes 2550-00-100 - Emphasys offset reamer, DePuy Synthes 4811-00-510 - Greatbatch Offset Cup Impactor, DePuy Synthes 2550-00-115 - Pinnacle straight impactor, DePuy Synthes 2217-50-041 - Emphasys straight impactor, DePuy Synthes 4812-00-150 - Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-002 (long) - Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-012 (short) - Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-001 (long) - Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-012 (short).
Summary parsed at:2026-06-24 03:56:50 UTC
