# K141840: Trabecular Metal Tibial Cone Broach, Trabecular Metal Coupled Tibial Cone Broach

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 3, 2014 after 57 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: 5 generations back to K982302 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102896: Trabecular Metal Tibial Cone Augments, Zimmer Trabecular Metal Technology (2010) Summary page 4.
- K120990: Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial, Zimmer Trabecular Metal Technology (2012) Summary page 4.

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

Source page: https://510kreport.com/device/K141840
Methodology: https://510kreport.com/methodology