# K040630: Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZ

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Sep 30, 2004 after 204 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
76 later devices descend from it; 3 cite it directly.
0 of 77 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
- K051756: Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ (2005), 75 descendants of its own
- K053340: Trabecular Metal Tibial and Femoral Cone Augments (2006), 74 descendants of its own
- K100391: Depuy Universal Gription TF Cones (2010), 53 descendants of its own
- K143393: Triathlon Tritanium Cone Augments (2015), 40 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own

## Recalls of this device
- Jul 5, 2010 · Not classified · Z-2440-2010: Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augm
- Jul 5, 2010 · Not classified · Z-2439-2010: Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augm

## Indications for use
The Trabecular Metal Femoral Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Femoral Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.

Source page: https://510kreport.com/device/K040630
Methodology: https://510kreport.com/methodology