# K964509: Implex a-240 Hep Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Jun 19, 1997 after 223 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 A-230 Porous Acetabular Cup System, Non-Cemented: named in the summary without a submission number

## Most influential descendants
- K021970: The Trabecular Metal Monoblock Cup, Models 00-7259-0XX-28 (Zimmer Cat. #) and 02-293-28XX1 (Implex Part #) (2002), 0 descendants of its own

## Recalls of this device
- 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
The use of the Implex A-240 HEP Acetabular Cup System is indicated for: a) Total Hip Replacement in severely disabled joints as a result of degenerative arthritis or avascular Necrosis; b) Secondary revision of a previously unsuccessful acetabular component; c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results; d) Fracture dislocation of the hip, or irreducible fractures in which adequate fixation cannot be obtained; Non-union of femoral neck or head fractures; and Salvage of a failed primary or secondary total or hemi hip.

Source page: https://510kreport.com/device/K964509
Methodology: https://510kreport.com/methodology