# K120906: Zimmer Trabecular Metal Total Ankle

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 24, 2012 after 151 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K920802 (1992). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920802: Alvine Total Ankle, Depuy, Inc. (1992) Summary page 1.
- K020541: Agility Ankle Revision Prosthesis, Depuy, Inc. (2002) Summary page 1.
- K060544: Salto Talaris Total Ankle Prosthesis, Tornier (2006) Summary page 1.

## Most influential descendants
- K250641: APEX 3D Total Ankle Replacement System (2025), 0 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0306-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Nov 12, 2013 · Class II · Z-0477-2014: As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels 
- Nov 12, 2013 · Class II · Z-0475-2014: As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels 
- Nov 12, 2013 · Class II · Z-0476-2014: As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels 

## Indications for use
Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint. The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: * Rheumatoid arthritis. * Post-traumatic arthritis. * Degenerative arthritis. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K120906
Methodology: https://510kreport.com/methodology