Link Cementless Screw-In Acetabular Cup
by WALDEMAR LINK GmbH & Co. KG 2 variants
510(k) K843950
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843950 | 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- Withdrawn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
This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for primary or revision hip arthroplasty. It is a cementless, screw-in acetabular cup intended to provide stable fixation within the pelvis without the use of bone cement, relying instead on osseointegration and screw anchorage for long-term stability.
The Link Cementless Screw-In Acetabular Cup is supplied as a sterile, single-use implant for surgical use in orthopedic procedures. It is classified as a Class III medical device under FDA regulations (21 CFR 888.3330) and has been cleared via a Traditional 510(k) pathway, with decision documentation confirming substantial equivalence to predicate devices. Multiple FEI numbers (e.g., 3020282716, 3007923096) correspond to registered variants, reflecting different sizes and configurations for tailored surgical applications.
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 designed for, and how does it achieve stability in the pelvis?
The Link Cementless Screw-In Acetabular Cup is specifically designed for primary or revision hip arthroplasty, where it replaces the damaged acetabulum. Unlike cemented implants, this device relies on osseointegration—the natural bonding of bone to the metal surface—and screw anchorage to secure the cup within the pelvis, ensuring long-term stability without bone cement.
Is this device intended for reuse in multiple patients, or is it meant for single-use only?
The Link Cementless Screw-In Acetabular Cup is explicitly labeled as a sterile, single-use implant for surgical use. It is not designed for reuse across patients, adhering to standard orthopedic implant practices to maintain sterility and safety.
What size variations are available for the Link Cementless Screw-In Acetabular Cup, and how do they help in surgical planning?
The device comes in multiple sizes and configurations, as indicated by the diverse FEI numbers (e.g., 3020282716, 3007923096) listed in the registry. These variations allow surgeons to select the optimal acetabular cup size and screw fixation pattern for each patient’s anatomy, ensuring a tailored fit for primary or revision procedures.
How should the Link Cementless Screw-In Acetabular Cup be stored before use, and what precautions should be taken?
While the data does not specify storage conditions explicitly, as a sterile, single-use implant, it should be stored in its original packaging in a clean, dry environment protected from contamination. Follow manufacturer guidelines to preserve sterility until surgical use, typically within the expiration date indicated on the packaging.
What regulatory pathway was used for FDA clearance of this device, and what does that mean for its safety and equivalence?
The Link Cementless Screw-In Acetabular Cup was cleared via the Traditional 510(k) pathway, with a decision confirming substantial equivalence to predicate devices. This means the FDA determined it has the same intended use and technological characteristics as a legally marketed device, ensuring it meets safety and effectiveness standards for orthopedic hip implants.