FIDJI Large Cement Restrictor
510(k) K030871
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESU | NumberK030871 | Date22 Dec 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDK
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESU
Overview
AI-generated summary, 1 Oct 2026
The FIDJI Large Cement Restrictor is a Prosthesis, Hip, Cement Restrictor, classified as a Class II medical device under FDA regulation 878.3300. This device is designed to restrict cement flow during hip arthroplasty procedures, ensuring controlled placement of bone cement within the acetabular component to enhance stability and reduce complications such as overfilling or leakage.
Supplied as a single-use device, the FIDJI Large Cement Restrictor is intended for use in orthopedic surgical settings. It is not MRI-safe and must be handled with sterile techniques. The device is packaged under sterile conditions and is regulated under FDA 510(k) clearance (K030871) with a decision dated December 22, 2003. Compliance with regulatory standards ensures its suitability for controlled cement application in hip replacement surgeries.
Other devices from Spine Next SA
Questions
AI-generated answers, 1 Oct 2026
What is the FIDJI Large Cement Restrictor used for?
The FIDJI Large Cement Restrictor is designed specifically for hip arthroplasty procedures. It restricts cement flow during the placement of bone cement in the acetabular component, helping surgeons achieve controlled application. This reduces risks like overfilling or leakage, which can compromise implant stability and increase complications.
Is the FIDJI Large Cement Restrictor single-use or reusable?
This device is intended for single-use only. It is supplied in sterile packaging, ensuring it remains uncontaminated for one surgical procedure. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.
How is the FIDJI Large Cement Restrictor supplied and stored?
The device comes pre-packaged under sterile conditions, ready for immediate use in the operating room. It should be stored in its original packaging until use to maintain sterility. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these can degrade the material or compromise its functionality.
Can the FIDJI Large Cement Restrictor be used with MRI?
No, the FIDJI Large Cement Restrictor is not MRI-safe. This means it should not be used in patients who require MRI imaging after surgery, as the device could interfere with the scan or pose a risk to the patient. Always confirm with your imaging facility before scheduling post-operative MRI scans.
What regulatory approval does the FIDJI Large Cement Restrictor hold?
The FIDJI Large Cement Restrictor holds FDA 510(k) clearance under the classification of Prosthesis, Hip, Cement Restrictor (product code JDK). The clearance was granted on December 22, 2003, following a traditional review process by the FDA. This approval ensures the device meets regulatory standards for controlled cement application in hip replacement surgeries.