# K033384: The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Nov 19, 2003 after 27 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- 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: 2 generations back to K023882 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
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) Summary page 2.
- K032282: Modification to Hedrocel Trabecular Metal Reconstruction System, Implex Corp. (2003)
- K032344: The Hedrocel Trabecular Metal Reconstruction System Model 10-330, Implex Corp. (2003) Summary page 2.

## 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/K033384
Methodology: https://510kreport.com/methodology