# K040487: Trabecular Metal Knee System Augments

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Dec 21, 2004 after 300 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982302 (1998). 2 ancestors in all.
85 later devices descend from it; 4 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024161: Nexgen Complete Knee Solution - Trabecular Metal Augments, Implex Corp. (2003) Summary page 1.

## Most influential descendants
- 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
- K053505: Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments (2006), 19 descendants of its own

## Recalls of this device
- Feb 4, 2015 · Class II · Z-1325-2015: One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.

## Indications for use
Trabecular Metal Knee System Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.

Source page: https://510kreport.com/device/K040487
Methodology: https://510kreport.com/methodology