# K972760: Link, Acetabular Revision Mesh Cup

- Pathway: 510(k) (Traditional)
- Applicant: Link America, Inc.
- Decided: Oct 22, 1997 after 90 days
- Product code: JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundatlon or base for the definitive load bearing acetabular cup-replacement devise.

Source page: https://510kreport.com/device/K972760
Methodology: https://510kreport.com/methodology