# K023882: The Hedrocel Trabecular Metal Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Feb 19, 2003 after 90 days
- Product code: EZX (Mesh, Surgical, Metal)
- 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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 no predicate by number.

## Most influential descendants
- K032344: The Hedrocel Trabecular Metal Reconstruction System Model 10-330 (2003), 2 descendants of its own
- K032282: Modification to Hedrocel Trabecular Metal Reconstruction System (2003), 1 descendant of its own
- K040756: The Trabecular Metal Reconstruction System, Model 10-340-Xxxxx (2004), 0 descendants of its own
- K033384: The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ (2003), 0 descendants of its own

## Indications for use
The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

Source page: https://510kreport.com/device/K023882
Methodology: https://510kreport.com/methodology