Ri.hip Modeler
by Blue Belt Technologies, Inc. 510(k)
Active
510(k) K212040
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212040 | Date11 Mar 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The RI.HIP MODELER is a standalone preoperative planning application for total hip arthroplasty (THA), designed to assist surgeons in evaluating acetabular cup positioning. It leverages patient-specific spinopelvic mobility data to assess implant impingement risks and optimize cup placement, reducing the likelihood of postoperative dislocation. As a radiology-related software tool, it integrates with preoperative imaging to enhance surgical planning accuracy. The device is classified under Product Code LLZ and is intended for use in orthopedic preoperative assessment.
The RI.HIP MODELER is supplied as a standalone iPad application and is intended for single-use per patient case, though the software itself may be reused across multiple procedures. It requires no sterilization and operates in a non-sterile clinical setting, such as an orthopedic preoperative planning station. The device is MRI-unsafe due to its electronic components and must be stored in a controlled environment to prevent unauthorized access or data corruption. Authorized under FDA 510(k) clearance (K212040), it adheres to regulatory standards for radiology software and orthopedic planning tools.
Other devices from Blue Belt Technologies, Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the RI.HIP MODELER in preoperative planning for hip replacement surgeries?
The RI.HIP MODELER is designed to assist surgeons in evaluating acetabular cup positioning during total hip arthroplasty (THA) by analyzing patient-specific spinopelvic mobility data. This helps identify potential implant impingement risks and optimizes cup placement, which can reduce the likelihood of postoperative dislocation. It integrates with preoperative imaging to improve surgical planning accuracy.
How is the RI.HIP MODELER supplied, and is it reusable across multiple procedures?
The RI.HIP MODELER is supplied as a standalone iPad application and is intended for single-use per patient case. However, the software itself can be reused across multiple procedures, as it does not require sterilization or physical disposal after each use. It operates in a non-sterile environment, such as an orthopedic preoperative planning station.
Does the RI.HIP MODELER require any special storage conditions, and why?
Yes, the RI.HIP MODELER must be stored in a controlled environment to prevent unauthorized access or data corruption. Since it contains electronic components and sensitive software, securing it ensures patient data integrity and maintains the software’s functionality for accurate preoperative planning.
Can the RI.HIP MODELER be used in an MRI environment, and if not, why?
No, the RI.HIP MODELER is not MRI-safe due to its electronic components. Since MRI environments require all devices to be non-metallic and non-electronic to avoid interference or safety hazards, this application cannot be used in such settings.
What regulatory pathway was followed for the approval of the RI.HIP MODELER, and what does this mean for its use?
The RI.HIP MODELER was authorized through the FDA’s 510(k) clearance process (K212040), specifically under the Traditional clearance type with a decision of Substantially Equivalent (SESE). This means the device was deemed comparable to a legally marketed predicate device in terms of technology and safety, ensuring it meets regulatory standards for radiology software and orthopedic preoperative assessment tools.