# K131283: Prophecy Infinity Preoperative Navigation Alignment Guides

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 5, 2013 after 60 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). 8 ancestors in all.
18 later devices descend from it; 4 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)
- K110360: Prophecy Inbone Pre-Operative Navigation Alignment Guides, Wrightmedicaltechnologyinc (2011) Summary page 1.
- K123954: Infinity Total Ankle System, Wrightmedicaltechnologyinc (2013)

## Most influential descendants
- 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
- K193432: Vantage PSI System (2020), 6 descendants of its own
- K202815: PROPHECY Preoperative Navigation Alignment System (2021), 3 descendants of its own
- K222835: Prophecy Preoperative Navigation Alignment System (2023), 2 descendants of its own

## Indications for use
Wright's PROPHECY Preoperative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The PROPHECY Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE and INFINITY Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY Preoperative Navigation Alignment Guides are intended for single use only.

Source page: https://510kreport.com/device/K131283
Methodology: https://510kreport.com/methodology