# K133585: Inbone Total Ankle

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 20, 2014 after 91 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: 5 generations back to K920802 (1992). 7 ancestors in all.
34 later devices descend from it; 5 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123954: Infinity Total Ankle System, Wrightmedicaltechnologyinc (2013) Summary page 1.
- K100886: Inbone II Total Ankle Replacement, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Most influential descendants
- K153008: INVISION Total Ankle Revision System (2016), 29 descendants of its own
- K142117: Invision Total Ankle Revision System (2015), 29 descendants of its own
- K162795: PROPHECY INVISION Preoperative Navigation Alignment System (2017), 17 descendants of its own
- K170968: PROPHECY INVISION Pre-operative Navigation System (2017), 16 descendants of its own
- K171067: INVISION Total Ankle Revision System (2017), 13 descendants of its own

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

Source page: https://510kreport.com/device/K133585
Methodology: https://510kreport.com/methodology