# K053340: Trabecular Metal Tibial and Femoral Cone Augments

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular
- Decided: Feb 27, 2006 after 88 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982302 (1998). 7 ancestors in all.
74 later devices descend from it; 9 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031962: Nexgen Trabecular Metal Tibial Cone Augments, Implex Corp. (2004) Summary page 1.
- K051756: Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ, Zimmer Trabecular (2005) Summary page 1.
- K040487: Trabecular Metal Knee System Augments, Implex Corp. (2004) Summary page 1.
- K031462: The Nexgen Knee System Uncemented Components, Implex Corp. (2003) Summary page 1.

## Most influential descendants
- 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
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own

## Indications for use
Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone 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 Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Ksiee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.

Source page: https://510kreport.com/device/K053340
Methodology: https://510kreport.com/methodology