# K120990: Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular Metal Technology
- Decided: Jun 29, 2012 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: 1 (0 Class I)
- 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.
7 later devices descend from it; 2 cite it directly.
0 of 17 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 2.
- K031962: Nexgen Trabecular Metal Tibial Cone Augments, Implex Corp. (2004) Summary page 2.
- K053340: Trabecular Metal Tibial and Femoral Cone Augments, Zimmer Trabecular (2006) 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.

## Most influential descendants
- 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
- K251717: Freedom® Total Knee System – Titanium Tibial Base Plate (2025), 1 descendant of its own
- K252777: Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (2025), 0 descendants of its own
- K253314: Freedom Infinia™ Total Knee System (2025), 0 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0325-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## Indications for use
The Trabecular Metal LCCK Coupled Tibial Cones 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 - Legacy Constrained Condylar knee System, the Trabecular Metal Coupled Tibial Cones are for cementless or cemented use.

Source page: https://510kreport.com/device/K120990
Methodology: https://510kreport.com/methodology