# K110360: Prophecy Inbone Pre-Operative Navigation Alignment Guides

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 16, 2011 after 311 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: 3 generations back to K920802 (1992). 3 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051023: Topez Total Ankle Replacement, Topez Orthopedics, Inc. (2005)

## Most influential descendants
- K131283: Prophecy Infinity Preoperative Navigation Alignment Guides (2013), 18 descendants of its own
- 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

## Indications for use
Wright's PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended for use with Wright's INBONE® 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® INBONE® Pre-Operative Navigation Alignment Guides are intended for single use only.

Source page: https://510kreport.com/device/K110360
Methodology: https://510kreport.com/methodology