# K032344: The Hedrocel Trabecular Metal Reconstruction System Model 10-330

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Oct 2, 2003 after 64 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
Longest line of descent: 1 generation back to K023882 (2003). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023882: The Hedrocel Trabecular Metal Reconstruction System, Implex Corp. (2003)

## Most influential descendants
- 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 be used with bone graft.

Source page: https://510kreport.com/device/K032344
Methodology: https://510kreport.com/methodology