Zimmer Threaded Acetabular Cup
by Zimmer, Inc.
510(k) K850766
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850766 | Date1 May 1985 | 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- Withdrawn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
- KWA
- Device class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). It is a threaded acetabular cup designed for hip arthroplasty, providing a metal, uncemented fixation to the pelvis for long-term stability in hip replacement procedures. The threaded design facilitates secure osseointegration with the surrounding bone, reducing the risk of loosening while supporting weight-bearing and rotational forces.
The Zimmer Threaded Acetabular Cup is intended for use in orthopedic settings, typically during primary or revision hip arthroplasty. It is supplied as a reusable surgical implant and is not sterile at the time of shipment, requiring terminal sterilization prior to use. The device is classified as a Class III medical device under FDA regulations and holds a FDA 510(k) clearance (K850766) for substantial equivalence. Multiple model references are associated with this product, ensuring compatibility with various surgical applications and patient anatomies.
Other devices from Zimmer, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of hip procedures is the Zimmer Threaded Acetabular Cup designed for, and how does its threaded design benefit patients?
The Zimmer Threaded Acetabular Cup is designed for use in primary or revision hip arthroplasty procedures. Its threaded design is engineered to provide secure, uncemented fixation to the pelvis, promoting osseointegration with the surrounding bone. This reduces the risk of loosening over time and supports weight-bearing and rotational forces, which is particularly important for long-term stability in hip replacements.
Is the Zimmer Threaded Acetabular Cup intended for single-use or can it be reused after sterilization?
The Zimmer Threaded Acetabular Cup is supplied as a reusable surgical implant. However, it is not sterile at the time of shipment and requires terminal sterilization prior to use. This means it can be reused after proper sterilization procedures are followed, ensuring safety and efficacy for subsequent procedures.
How many model references are available for the Zimmer Threaded Acetabular Cup, and what does this mean for surgical flexibility?
The Zimmer Threaded Acetabular Cup comes with multiple model references, totaling over 40 distinct variants as listed in the provided data. This variety ensures compatibility with different surgical applications and patient anatomies, allowing surgeons to select the most appropriate size and design for each individual case.
What sterilization method is required for the Zimmer Threaded Acetabular Cup before use, and why isn’t it sterile upon receipt?
The Zimmer Threaded Acetabular Cup is not sterile at the time of shipment, which is typical for reusable surgical implants. Terminal sterilization must be performed before use, ensuring the device meets strict safety standards for surgical applications. This process is essential to eliminate any potential contaminants and ensure patient safety during hip arthroplasty procedures.
What regulatory pathway was followed for the Zimmer Threaded Acetabular Cup, and what does this mean for its use in clinical settings?
The Zimmer Threaded Acetabular Cup was cleared through the FDA’s 510(k) pathway, specifically under a Traditional review with a decision of Substantial Equivalence (SESE). This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness. Clinicians can rely on this clearance when selecting the device for orthopedic procedures.