# K072160: Nexgen Trabecular Metal Tibial Tray

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Sep 5, 2007 after 30 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: 3 generations back to K933785 (1995). 5 ancestors in all.
108 later devices descend from it; 6 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components, Zimmer, Inc. (2003) Summary page 1.

## Most influential descendants
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K123486: Triathlon Tritanium Tibial Baseplate (2013), 51 descendants of its own
- K132624: Triathlon Tritanium Metal-Backed Patella (2013), 38 descendants of its own
- K141056: Triathlon Knee System Posterior Stabilized Components (2014), 28 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own

## Recalls of this device
- Nov 16, 2009 · Not classified · Z-1064-2010: The titanium portion of the implant may separate from the trabecular metal material.

## Indications for use
This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation).

Source page: https://510kreport.com/device/K072160
Methodology: https://510kreport.com/methodology