# K020541: Agility Ankle Revision Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: May 20, 2002 after 90 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
Longest line of descent: 1 generation back to K920802 (1992). 1 ancestor in all.
66 later devices descend from it; 6 cite it directly.
0 of 68 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 2.

## Most influential descendants
- K051023: Topez Total Ankle Replacement (2005), 64 descendants of its own
- K100886: Inbone II Total Ankle Replacement (2010), 56 descendants of its own
- K123954: Infinity Total Ankle System (2013), 52 descendants of its own
- K140749: Infinity Total Ankle System (2014), 48 descendants of its own
- K133585: Inbone Total Ankle (2014), 34 descendants of its own

## Indications for use
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis. The Agility Ankle Revision Prosthesis is additionally indicated for patients with a failed previous ankle surgery. CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.

Source page: https://510kreport.com/device/K020541
Methodology: https://510kreport.com/methodology