Howmedica Threaded Acetabular Component
by Pfizer Inc. 510(k)
Active
510(k) K850840
Overview
This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), as classified by the FDA. It is designed as a metal acetabular cup intended for uncemented fixation within the pelvis, providing a bearing surface for hip arthroplasty. The threaded design facilitates secure osseointegration with the native bone, offering rotational and translational stability without a cemented interface.
The Howmedica Threaded Acetabular Component is supplied in multiple sizes and variants, as indicated by the listed FEI numbers, and is intended for surgical implantation during total hip replacement procedures. It is classified as a Class III device under FDA regulations and was granted FDA 510(k) clearance under the Traditional pathway. The device is non-sterile upon receipt and must be sterilized by the surgical facility prior to use. No specific MRI safety information is provided in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850840 | Date15 Jul 1985 | 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- Withdrawn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
- KWA
- FDA applicant
- Pfizer, Inc.
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pfizer Inc.
Questions
What types of hip replacement surgeries is this acetabular component designed for, and why is the threaded design important?
This Howmedica Threaded Acetabular Component is specifically designed for total hip replacement procedures where an uncemented acetabular cup is required. The threaded design is critical because it enables secure osseointegration with the patient’s native pelvic bone, providing rotational and translational stability without relying on cement. This helps reduce the risk of loosening over time, which is a common complication in hip arthroplasty.
How many sizes and variants of this acetabular component are available, and how are they identified?
This device comes in multiple sizes and variants, each identified by unique FEI numbers. There are over 50 distinct FEI numbers listed, such as 3020282716, 3007923096, and 1818910, which correspond to different dimensions and configurations to accommodate varying patient anatomies during total hip replacement.
Is this device sterile when received, and what sterilization process should be used before surgery?
No, the Howmedica Threaded Acetabular Component is not sterile upon receipt. It must be sterilized by the surgical facility prior to use, as indicated in the regulatory data. The facility should follow established sterilization protocols to ensure safety and efficacy before implantation.
Can this acetabular component be reused after a single surgical procedure, or is it intended for single-use only?
The device is intended for single-use only, as is standard practice for orthopedic implants to prevent cross-contamination and ensure patient safety. Reuse is not recommended or supported by the manufacturer’s design or regulatory classification.
Is there any information provided about MRI safety for this acetabular component?
The regulatory data does not include any specific details regarding MRI safety for this Howmedica Threaded Acetabular Component. If MRI imaging is required post-implantation, clinicians should consult the manufacturer’s updated guidelines or alternative imaging modalities to avoid potential risks.