# K102896: Trabecular Metal Tibial Cone Augments

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular Metal Technology
- Decided: Dec 13, 2010 after 74 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
No predicates in its family tree.
17 later devices descend from it; 7 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NexGen Trabecular Metal Tibial Cone Augments: named in the summary without a submission number

## Most influential descendants
- K120990: Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial (2012), 7 descendants of its own
- K182346: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws (2018), 5 descendants of its own
- K241597: Freedom® Total Knee System - Porous Tibial Base Plate (2025), 3 descendants of its own
- K200653: AMF Revision TT Cones (2020), 3 descendants of its own
- K251717: Freedom® Total Knee System – Titanium Tibial Base Plate (2025), 1 descendant of its own

## 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/K102896
Methodology: https://510kreport.com/methodology