# K012866: The Nexgen TMT Tibia, Models 00-5886-Xxyy, 05-120-Xxyy-0

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Sep 26, 2001 after 30 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Mar 27, 2013 · Class II · Z-1376-2013: Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to no

## Indications for use
The NexGen® TMT Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.

Source page: https://510kreport.com/device/K012866
Methodology: https://510kreport.com/methodology