# K103374: Inbone Total Ankle System Model 200347902

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 14, 2010 after 27 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.
54 later devices descend from it; 4 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K085102: INBONE Total Ankle System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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

## 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 ankle prosthesis 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/K103374
Methodology: https://510kreport.com/methodology