Porous-Coated Titanium Acetabular Cup
by Dow Corning Wright 510(k)
Active
510(k) K894965
Overview
The Porous-Coated Titanium Acetabular Cup is a semi-constrained, metal cemented acetabular component designed for hip replacement surgery. This device features a porous coating on a titanium substrate to enhance osseointegration, providing stability and promoting long-term fixation within the pelvic bone.
Intended for use in orthopedic settings, the Porous-Coated Titanium Acetabular Cup is supplied sterile and intended for single-use. It is classified as a Class III medical device under FDA regulations and holds a 510(k) clearance for substantial equivalence in specific indications. Multiple model variants are available, as indicated by the associated registration numbers, and must be handled and stored according to manufacturer guidelines to maintain sterility and performance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK894965 | Date17 Nov 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- Withdrawn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
- JDL
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3320
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Other devices from Dow Corning Wright
Questions
What types of hip replacement surgeries is the Porous-Coated Titanium Acetabular Cup designed for, and how does its porous coating benefit the patient?
The Porous-Coated Titanium Acetabular Cup is designed for use in hip replacement surgeries where a semi-constrained, metal cemented acetabular component is required. The porous coating on the titanium substrate enhances osseointegration, which means it encourages bone growth into the coating, providing better stability and promoting long-term fixation within the pelvic bone. This helps reduce the risk of loosening over time.
Is the Porous-Coated Titanium Acetabular Cup intended for reuse, or is it meant to be used only once? How should it be handled to maintain sterility?
The Porous-Coated Titanium Acetabular Cup is supplied sterile and intended for single-use only. To maintain sterility and performance, it must be handled according to the manufacturer’s guidelines, which likely include keeping it in its sealed packaging until use and avoiding contamination during surgical preparation.
How many model variants of this acetabular cup are available, and how can I identify the correct one for my patient’s procedure?
Multiple model variants of the Porous-Coated Titanium Acetabular Cup are available, as indicated by the associated registration numbers (e.g., 8043792, 2242737, etc.). The correct variant should be selected based on the patient’s anatomy, surgical requirements, and the surgeon’s preference. Always refer to the manufacturer’s documentation or consult with Dow Corning Wright to ensure the right model is chosen for the procedure.
What storage conditions should be followed to ensure the device remains effective until use?
While the exact storage conditions are not detailed here, the device is supplied sterile and must be stored according to manufacturer guidelines to preserve sterility and performance. Typically, this includes keeping it in its original packaging, away from extreme temperatures, moisture, and contamination until ready for use. Always follow the instructions provided by Dow Corning Wright.