# K020295: Nexgen LPS Trabecular Metal Monoblock Tibia; Zimmer Cat # 00-5886-Xxyy, Implex Part # 05-121-Xxyy-0

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Feb 12, 2002 after 15 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 LPS Trabecular Metal Monoblock 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/K020295
Methodology: https://510kreport.com/methodology