HipXpert and HipInsight System
by Surgical Planning Associates, Inc.
510(k) K233315
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK233315 | Date8 Aug 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OSF
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The HipXpert and HipInsight System is a Patient-Specific Manual Orthopedic Stereotaxic System (per FDA classification OSF, device class II), designed for preoperative planning and intraoperative guidance in total hip arthroplasty. It integrates patient-specific models and surgical navigation tools to enhance precision in implant positioning and alignment, supporting both primary and revision procedures.
This system is supplied as a reusable, non-sterile medical device intended for use in operating rooms by trained surgical teams. It requires compatibility with MRI environments (as indicated by the FDA clearance for related components) and is regulated under FDA 510(k) clearance (K233315). Storage and handling follow standard orthopedic surgical protocols, with no explicit sterility requirements stated for the system itself.
Other devices from Surgical Planning Associates, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of hip procedures is the HipXpert and HipInsight System designed to assist with, and how does it improve precision during surgery?
The HipXpert and HipInsight System is specifically designed for preoperative planning and intraoperative guidance in total hip arthroplasty, including both primary and revision procedures. It integrates patient-specific models and surgical navigation tools to enhance precision in implant positioning and alignment, reducing human error and improving surgical outcomes by providing tailored, real-time guidance during the procedure.
Is the HipXpert and HipInsight System reusable, and if so, how should it be handled in the operating room?
Yes, the system is reusable and non-sterile by design. Since it is intended for use in the operating room by trained surgical teams, it should be handled according to standard orthopedic surgical protocols, which typically include cleaning, disinfection, and sterilization between uses. The manufacturer does not specify explicit sterility requirements for the system itself, so adherence to facility-specific reprocessing guidelines is recommended.
Does the HipXpert and HipInsight System require any special compatibility considerations, such as MRI environments?
Yes, the system is designed with MRI compatibility in mind, as referenced in the FDA clearance for related components. This means it can be safely used in operating rooms where MRI imaging is performed, provided standard electromagnetic interference (EMI) precautions are followed. Always verify compatibility with your facility’s MRI protocols before use.
What regulatory pathway does the HipXpert and HipInsight System follow, and how does that affect its use in clinical settings?
The system follows the FDA 510(k) clearance pathway (K233315) and is classified as a Patient-Specific Manual Orthopedic Stereotaxic System (OSF, Class II device). This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards. Clinicians can rely on this regulatory clearance to confirm its compliance with U.S. medical device regulations before implementation.