# K983128: Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy, 02-247-Xxyyy, 02-248-Xxyyy

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Dec 3, 1998 after 86 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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 Hedrocel® Porous Acetabular Cup System: named in the summary without a submission number
- (no number) Implex Replacement Acetabular Cup Insert System: named in the summary without a submission number
- (no number) Osteonics GAP II Restoration Acetabular shell with Omnifit® Polyethylene Insert Bearing: named in the summary without a submission number

## Most influential descendants
- K051516: Trabecular Metal Revision Shell Liners (2005), 5 descendants of its own
- K072121: Trabecular Metal Acetabular Revision System Cemented Contrained Liner (2008), 3 descendants of its own
- K181366: REDAPT Porous Acetabular Shell (2018), 1 descendant of its own
- K253630: Mpact 3D Metal Foam (2026), 0 descendants of its own
- K243571: Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (2025), 0 descendants of its own

## 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

## Indications for use
The Implex Hedrocel® Replacement Cup Insert, cemented, is intended for use as an in-situ replacement polyethylene bearing surface under circumstances of joint instability, wear and/or damage caused by the patient during use.

Source page: https://510kreport.com/device/K983128
Methodology: https://510kreport.com/methodology