# K230462: OPTIX H2 Patient Specific Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Jul 17, 2023 after 146 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: 8 generations back to K920802 (1992). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171004: Hintermann Series H2 Total Ankle System, Dt Medtech, LLC (2017) Summary page 4.

## Indications for use
The OPTIX H2 Patient Specific Instrument System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The OPTIX H2 Patient Specific Instrument System is intended for use with Vilex’s Hintermann Series H2 Total Ankle System and its cleared indications for use. The OPTIX H2 Patient Specific Instrument System is indicated for single use only and is generated from CT imaging data.

Source page: https://510kreport.com/device/K230462
Methodology: https://510kreport.com/methodology