# K100886: Inbone II Total Ankle Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 26, 2010 after 149 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920802 (1992). 3 ancestors in all.
56 later devices descend from it; 8 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051023: Topez Total Ankle Replacement, Topez Orthopedics, Inc. (2005)

## Most influential descendants
- 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
- K153008: INVISION Total Ankle Revision System (2016), 29 descendants of its own
- K142117: Invision Total Ankle Revision System (2015), 29 descendants of its own

## Recalls of this device
- Nov 4, 2021 · Class II · Z-0315-2022: The package contents and package labeling do not match.
- Nov 4, 2021 · Class II · Z-0316-2022: The package contents and package labeling do not match.

## Indications for use
The INBONETm Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INBONETm Total Ankle is additionally indicated for patients with a failed previous ankle surgery. CAUTION: The ankle prosthesis is intended for cement use only.

Source page: https://510kreport.com/device/K100886
Methodology: https://510kreport.com/methodology