Link Cementless Screw-in Acetabular Cup
by WALDEMAR LINK GmbH & Co. KG 2 variants
510(k) K843940
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843940 | Date3 Jun 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- Withdrawn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
The Link Cementless Screw-in Acetabular Cup is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). It is designed as a cementless, screw-in acetabular cup for total hip arthroplasty, providing a secure fixation to the pelvis without the use of bone cement. Constructed from metal, this device is intended to replace the damaged or diseased acetabulum, restoring joint function and stability.
This acetabular cup is supplied sterile and intended for single-use in orthopedic surgical procedures. It is classified as a Class III device under FDA regulations and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The device is available in multiple sizes and configurations, as indicated by the listed registration numbers, and must be handled and stored according to manufacturer guidelines to maintain sterility and integrity prior to use.
Other devices from WALDEMAR LINK GmbH & Co. KG
Questions
AI-generated answers, 18 Sep 2026
What types of hip surgeries is the Link Cementless Screw-in Acetabular Cup intended for?
The Link Cementless Screw-in Acetabular Cup is specifically designed for total hip arthroplasty procedures where the damaged or diseased acetabulum (hip socket) needs replacement. It is a cementless, screw-in acetabular component, meaning it is secured to the pelvis without bone cement, providing stable fixation for restoring joint function and stability in patients with severe hip joint issues.
How is the Link Cementless Screw-in Acetabular Cup supplied, and is it reusable?
The device is supplied sterile and is intended for single-use only in orthopedic surgical procedures. It is not designed for reuse, and proper handling and storage guidelines must be followed to maintain sterility and integrity before use.
What size options are available for the Link Cementless Screw-in Acetabular Cup?
The device comes in multiple sizes and configurations, as indicated by the listed registration numbers (e.g., 8043792, 3020282716, etc.). These variations allow for customization to fit different patient anatomies during total hip arthroplasty. The exact sizing details should be referenced in the manufacturer’s technical documentation or surgical guides.
How should the Link Cementless Screw-in Acetabular Cup be stored to ensure it remains sterile and intact?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and structural integrity. Since it is supplied sterile and single-use, it should be kept in its original packaging until immediately before use, protected from contamination, moisture, and physical damage.
What regulatory pathway was followed for FDA clearance of this device?
The Link Cementless Screw-in Acetabular Cup received FDA 510(k) clearance under the Traditional Review pathway, determined to be *substantially equivalent* to a predicate device. The clearance was granted by the Orthopedic (OR) Advisory Committee in 1985, and the device is classified as a Class III medical device under FDA regulations.