# K024161: Nexgen Complete Knee Solution - Trabecular Metal Augments

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Jan 15, 2003 after 29 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
Longest line of descent: 1 generation back to K982302 (1998). 1 ancestor in all.
106 later devices descend from it; 6 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982302: Implex Continuum Knee - Hedrocel Tibial Spacers, Implex Corp. (1998) Summary page 2.

## Most influential descendants
- K040487: Trabecular Metal Knee System Augments (2004), 85 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
- Feb 1, 2019 · Class II · Z-1005-2019: Potentially comingled, resulting in the product in the box potentially not matching the product on the label
- Feb 1, 2019 · Class II · Z-1006-2019: Potentially comingled, resulting in the product in the box potentially not matching the product on the label

## Indications for use
The NexGen Trabecular Metal femoral and tibial 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 and tibial augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.

Source page: https://510kreport.com/device/K024161
Methodology: https://510kreport.com/methodology