# K191380: Quantum® Total Ankle Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Jan 29, 2020 after 251 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: 7 generations back to K920802 (1992). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090076: Salto Talaris Total Ankle Prosthesis, Tornier (2009) Summary page 5.
- K153452: Salto XT, Salto Talaris, Tornier S.A.S. (2016) Summary page 5.
- K151459: Integra Total Ankle Replacement System, Ascension Orthopedics (2015) Summary page 5.
- K152217: Exactech Vantage Total Ankle System, Exactech, Inc. (2016) Summary page 5.

## Indications for use
The Quantum® total ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Note: In the United States, the ankle prosthesis is intended for cement use only.

Source page: https://510kreport.com/device/K191380
Methodology: https://510kreport.com/methodology