Resolve Modular Revision Hip Stem
by United Orthopedic Corporation
510(k) K242315
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK242315 | Date1 May 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- MEH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Resolve Modular Revision Hip Stem is a modular orthopedic implant classified as a hip prosthesis, designed for revision arthroplasty procedures. It provides a modular system to accommodate varying anatomical requirements, facilitating secure fixation and restoring hip joint function in complex cases where primary implants have failed or require replacement.
This device is intended for surgical use in orthopedic settings and is supplied sterile for single-use. The modular design allows for customization to fit individual patient anatomy, with sizes and configurations determined by the surgeon during implantation. Authorized under FDA 510K clearance, MDD, and MDR compliance, it adheres to regulatory standards for orthopedic revision implants.
From the manufacturer
Manufacturer's product page: Hip System
Other devices from United Orthopedic Corporation
Questions
AI-generated answers, 18 Sep 2026
What types of patients is the Resolve Modular Revision Hip Stem designed to help, and how does its modularity benefit them?
The Resolve Modular Revision Hip Stem is specifically designed for patients undergoing revision hip arthroplasty, where primary hip implants have failed or require replacement. Its modular system allows surgeons to customize the implant to match individual patient anatomy, ensuring a secure fit and restoring hip joint function. This adaptability is particularly valuable in complex cases where anatomical variations or bone loss require tailored solutions.
Is the Resolve Modular Revision Hip Stem intended for reuse, or is it meant to be used only once per patient?
The Resolve Modular Revision Hip Stem is supplied sterile and explicitly intended for single-use only. This ensures patient safety and sterility standards are maintained, as reuse could compromise integrity and introduce infection risks.
How does the surgeon determine the appropriate size and configuration for the Resolve Modular Revision Hip Stem during surgery?
The surgeon selects the size and configuration of the Resolve Modular Revision Hip Stem based on intraoperative assessment of the patient’s anatomy and the specific revision requirements. The modular design allows for real-time adjustments to accommodate varying bone structures, ensuring optimal fixation and alignment during the procedure.
What regulatory pathways has the Resolve Modular Revision Hip Stem undergone, and what does that mean for its use?
The Resolve Modular Revision Hip Stem has been authorized through FDA 510K clearance, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). This means the device has met stringent regulatory standards for safety, performance, and manufacturing quality, ensuring it can be confidently used in clinical settings for revision hip arthroplasty procedures.