# K031462: The Nexgen Knee System Uncemented Components

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Aug 6, 2003 after 90 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
128 later devices descend from it; 4 cite it directly.
0 of 129 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 TMT Tibia: named in the summary without a submission number
- (no number) LPS Tibia: named in the summary without a submission number
- (no number) Primary Porous Patella: named in the summary without a submission number

## Most influential descendants
- K053340: Trabecular Metal Tibial and Femoral Cone Augments (2006), 74 descendants of its own
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known (2004), 60 descendants of its own
- K100391: Depuy Universal Gription TF Cones (2010), 53 descendants of its own
- K060303: Vanguard PS Open Box Porous Femoral Components (2006), 47 descendants of its own
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own

## Recalls of this device
- Apr 15, 2016 · Class II · Z-1951-2016: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual
- Apr 15, 2016 · Class II · Z-1953-2016: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual
- Apr 15, 2016 · Class II · Z-1950-2016: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual
- Apr 15, 2016 · Class II · Z-1952-2016: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual

## Indications for use
Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty.

Source page: https://510kreport.com/device/K031462
Methodology: https://510kreport.com/methodology