Modified Gemini Acetabular Cup
by Depuy, Inc. 510(k)
Active
510(k) K894298
Overview
The Modified Gemini Acetabular Cup is a prosthetic component designed for hip replacement surgery, specifically intended for use as an acetabular shell in total hip arthroplasty. It is classified under orthopedic implants and serves to replace the damaged or diseased acetabulum, providing a stable bearing surface for the femoral head component. Constructed to integrate with the pelvic bone, it helps restore joint function and alleviate pain in patients with degenerative joint conditions, such as osteoarthritis or rheumatoid arthritis.
This device is supplied as a single-use implant and is regulated under FDA 510(k) clearance (K894298), with a traditional review process through the Orthopedic (OR) Advisory Committee. It is intended for use in sterile surgical environments and requires proper sterilization before implantation. The product code JDI categorizes it within the regulatory framework, and its design is substantiated for some indications as substantially equivalent to prior devices. Storage and handling must comply with medical device sterilization standards to ensure integrity and safety prior to surgical use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK894298 | Date27 Sep 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- JDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3350
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Other devices from Depuy, Inc.
Questions
What is the Modified Gemini Acetabular Cup used for?
The Modified Gemini Acetabular Cup is a prosthetic component intended for use in total hip arthroplasty (hip replacement surgery). It replaces the damaged or diseased acetabulum—the socket portion of the hip joint—to provide a stable bearing surface for the femoral head component. This helps restore joint function, improve mobility, and relieve pain in patients suffering from degenerative joint conditions such as osteoarthritis or rheumatoid arthritis.
Is the Modified Gemini Acetabular Cup intended for single-use or reuse?
The Modified Gemini Acetabular Cup is designed for single-use only. As a surgical implant, it is not intended to be reused after implantation to ensure patient safety and sterility. Single-use implants are manufactured and packaged under strict sterilization protocols to prevent contamination and maintain integrity before surgical use.
How is the Modified Gemini Acetabular Cup sterilized before use?
The Modified Gemini Acetabular Cup is supplied in a sterile package, requiring adherence to medical device sterilization standards before surgical use. The manufacturer ensures sterility through validated processes, and the device must remain unopened and protected from contamination until implantation. Proper storage conditions, as outlined in the accompanying documentation, are critical to maintaining its sterility and functionality.
What regulatory pathway does the Modified Gemini Acetabular Cup follow?
The Modified Gemini Acetabular Cup received FDA clearance through the 510(k) process, specifically under clearance number K894298. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device for some indications. The review was conducted through the Orthopedic (OR) Advisory Committee, ensuring its safety and effectiveness for its intended use in hip replacement surgery.
How should the Modified Gemini Acetabular Cup be stored prior to use?
The Modified Gemini Acetabular Cup must be stored in its original, unopened packaging to preserve sterility and prevent damage. Storage conditions should comply with medical device guidelines, typically involving a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. Always follow the manufacturer’s instructions for storage duration and handling to ensure the device remains safe and functional for surgical use.