# K162795: PROPHECY INVISION Preoperative Navigation Alignment System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 22, 2017 after 141 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). 13 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 31 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). Our reading of the summary gave K110306, FDA’s number for Sound Surgical Vaser 2.1 Lipo System (Sound Surgical Technologies, LLC). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “PROPHECY® INBONE®”.
- K131283: Prophecy Infinity Preoperative Navigation Alignment Guides, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K142117: Invision Total Ankle Revision System, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K153008: INVISION Total Ankle Revision System, Wrightmedicaltechnologyinc (2016) Summary page 4.

## Most influential descendants
- 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
- K211883: QUANTUM® Patient Specific Instrumentation (PSI) System (2021), 2 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 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. The PROPHECY® Preoperative 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.

Source page: https://510kreport.com/device/K162795
Methodology: https://510kreport.com/methodology