# K123059: Inbone ( I and II) Total Ankle Systems

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 4, 2013 after 154 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: 4 generations back to K920802 (1992). 5 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 27 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) Summary page 1.
- K103374: Inbone Total Ankle System Model 200347902, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K100886: Inbone II Total Ankle Replacement, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Most influential descendants
- K141740: Infinity (TM) Total Ankle System; Inbone Total Ankle System (2015), 17 descendants of its own
- K171067: INVISION Total Ankle Revision System (2017), 13 descendants of its own
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System (2020), 8 descendants of its own
- K180730: INVISION Total Ankle Revision System (2018), 3 descendants of its own
- K210390: Apex 3D Total Ankle Replacement System (2021), 2 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 cement use only.

Source page: https://510kreport.com/device/K123059
Methodology: https://510kreport.com/methodology