# K980486: Implex Hep Acetabular Revision Cup, Cemented or Cementless Model a-240 System

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Apr 14, 1998 after 64 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 2 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Implex HEP Porous Acetabular Cup System, Cemented and Cementless: named in the summary without a submission number
- (no number) Implex Porous Elliptical Revision Cup System, Cemented and Cementless: named in the summary without a submission number
- (no number) Implex Acetabular Cup Screw System: named in the summary without a submission number

## Recalls of this device
- Apr 15, 2016 · Class II · Z-1954-2016: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual
- Apr 15, 2016 · Class II · Z-1955-2016: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual

## Indications for use
Intended for use in the acetabulum where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless, or hybrid total hip arthroplasty.

Source page: https://510kreport.com/device/K980486
Methodology: https://510kreport.com/methodology