# K040756: The Trabecular Metal Reconstruction System, Model 10-340-Xxxxx

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Jul 14, 2004 after 112 days
- Product code: FTM (Mesh, Surgical)
- 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)
- K032344: The Hedrocel Trabecular Metal Reconstruction System Model 10-330, Implex Corp. (2003) Summary page 1.
- K962468: Hedrocel Acetabular Restrictor, Implex Corp. (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K023388: Mitek Rapidloc-PDS Meniscal Repair System, Mitek Worldwide (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The 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 Trabecular Metal Reconstruction System may also be used with bone graft.

Source page: https://510kreport.com/device/K040756
Methodology: https://510kreport.com/methodology