# K103517: Trabecular Metal Femoral Cone Augments

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular Metal Technology, Inc.
- Decided: Feb 15, 2011 after 77 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: 4 generations back to K982302 (1998). 9 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040630: Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZ, Implex Corp. (2004) Summary page 2.
- K051756: Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ, Zimmer Trabecular (2005) Summary page 2.
- K053340: Trabecular Metal Tibial and Femoral Cone Augments, Zimmer Trabecular (2006) Summary page 2.
- K031962: Nexgen Trabecular Metal Tibial Cone Augments, Implex Corp. (2004) Summary page 2.
- K024161: Nexgen Complete Knee Solution - Trabecular Metal Augments, Implex Corp. (2003) Summary page 2.
- K040487: Trabecular Metal Knee System Augments, Implex Corp. (2004) Summary page 2.
- K982302: Implex Continuum Knee - Hedrocel Tibial Spacers, Implex Corp. (1998) Summary page 2.
- K980781: Implex Continuum Knee- Hedrocel Revision Femoral Spacers, Implex Corp. (1998)

## Most influential descendants
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K200653: AMF Revision TT Cones (2020), 3 descendants of its own
- K240324: EMPOWR Revision Symmetric Knee Cones (2024), 1 descendant of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K251241: EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K103517
Methodology: https://510kreport.com/methodology