# K202815: PROPHECY Preoperative Navigation Alignment System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 10, 2021 after 167 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: 9 generations back to K920802 (1992). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170968: PROPHECY INVISION Pre-operative Navigation System, Wrightmedicaltechnologyinc (2017) Summary page 4.
- K162795: PROPHECY INVISION Preoperative Navigation Alignment System, Wrightmedicaltechnologyinc (2017) Summary page 4.
- K131283: Prophecy Infinity Preoperative Navigation Alignment Guides, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K110360: Prophecy Inbone Pre-Operative Navigation Alignment Guides, Wrightmedicaltechnologyinc (2011) Summary page 4.

## Most influential descendants
- K222835: Prophecy Preoperative Navigation Alignment System (2023), 2 descendants of its own
- K241999: Prophecy Surgical Planning System (2024), 1 descendant of its own
- K253159: Prophecy Incompass Surgical Planning System (2026), 0 descendants of its own

## Indications for use
Wright’s PROPHECY™ Preoperative Navigation Alignment System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The PROPHECY™ Preoperative Navigation Alignment Guides and Reports are intended for use with Wright’s INBONE™, INFINITY™ and INVISION™ 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/K202815
Methodology: https://510kreport.com/methodology