# K920802: Alvine Total Ankle

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Dec 17, 1992 after 300 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
68 later devices descend from it; 6 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020541: Agility Ankle Revision Prosthesis (2002), 66 descendants of its own
- K051023: Topez Total Ankle Replacement (2005), 64 descendants of its own
- K100886: Inbone II Total Ankle Replacement (2010), 56 descendants of its own
- K053569: Agility LP Total Ankle Prosthesis (2006), 53 descendants of its own
- K123954: Infinity Total Ankle System (2013), 52 descendants of its own

Source page: https://510kreport.com/device/K920802
Methodology: https://510kreport.com/methodology