Link Metal-Backed Acetabular Cups

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K854935 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Link Cortical Screws

  Class II

  FDA 510(k) K854827 Active Cleared 27 Dec 1985

• Link Contour Ribbed Hip Prostheses System

  Class II

  FDA 510(k) K854465 Active Cleared 10 Feb 1986

• Link Ceramic Heads 12/14 X 32mm

  Class II

  FDA 510(k) K931571 Active Cleared 19 Apr 1994

• Schwabe Radius Plates

  Class II

  FDA 510(k) K914803 Active Cleared 28 Apr 1992

• Radius Osteotomy Plates

  Class II

  FDA 510(k) K914804 Active Cleared 29 Apr 1992

• Link Dynamic Staple

  Class II

  FDA 510(k) K853704 Active Cleared 21 Jan 1986

See all devices from Link America, Inc. →

• What type of hip arthroplasty procedures are these metal-backed acetabular cups designed for, and how do they function in the body?

  The Link Metal-Backed Acetabular Cups are semi-constrained, metal cemented components specifically designed for hip arthroplasty to replace a damaged acetabulum. They provide a stable bearing surface for the femoral head prosthesis, ensuring proper articulation and restoring hip joint function and mobility. The metal backing enhances durability and stability, making them suitable for reconstructive surgeries where a secure fit is critical.

• Are these acetabular cups reusable, and if so, what considerations should be taken during surgical procedures?

  Yes, the Link Metal-Backed Acetabular Cups are supplied as reusable surgical implants. Since they are intended for reuse, they must be thoroughly cleaned, sterilized, and inspected between procedures to maintain sterility and integrity. Proper handling and storage in a controlled surgical environment are essential to prevent contamination and ensure safe use in subsequent surgeries.

• How do I determine the correct size for a patient when selecting these acetabular cups?

  The provided data does not specify sizing details for the Link Metal-Backed Acetabular Cups, so sizing must be determined through preoperative planning and intraoperative assessment by the surgeon. Typically, acetabular cup sizes are selected based on the patient’s anatomy, pelvic dimensions, and the specific surgical technique being used. Consulting the manufacturer’s sizing guides or working with an orthopedic specialist ensures the best fit for the patient’s needs.

• What regulatory pathway was followed for FDA clearance of these acetabular cups, and what does that mean for clinicians?

  The Link Metal-Backed Acetabular Cups received FDA clearance through a 510(k) submission with a traditional review process, categorized under device class 3 and the Orthopedic advisory committee. This means the device was deemed substantially equivalent to a legally marketed predicate, ensuring it meets established safety and effectiveness standards. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though individual surgical outcomes depend on proper selection, implantation, and postoperative care.