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Prophecy Invision Pre-operative Navigation System

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K170968

Overview

The Prophecy Invision Pre-operative Navigation System is a Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer device designed for pre-operative planning and alignment guidance in total ankle arthroplasty. It provides surgical navigation tools to ensure precise implant positioning by leveraging patient-specific imaging data to identify anatomical landmarks for alignment and component placement.

This system is intended for single-use in orthopedic surgical settings and is supplied as a sterile, pre-packaged kit. It is classified under FDA regulation 888.3110 and holds a FDA 510(k) clearance (K170968) for use with Wright’s INBONE, INFINITY, and INVISION Total Ankle Systems. The device adheres to Class II special controls and is intended for use only when necessary anatomical landmarks are identifiable on patient imaging scans.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170968 Date16 Aug 2017ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HSN
Device Class
Class II
Regulation
21 CFR Part 888.3110
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the Prophecy Invision Pre-operative Navigation System in total ankle arthroplasty?

    The Prophecy Invision Pre-operative Navigation System is designed to assist surgeons in pre-operative planning and alignment guidance for total ankle arthroplasty. It uses patient-specific imaging data to identify anatomical landmarks, ensuring precise implant positioning for Wright’s INBONE, INFINITY, and INVISION Total Ankle Systems.

  • Is the Prophecy Invision Pre-operative Navigation System intended for single-use or reusable applications?

    The Prophecy Invision Pre-operative Navigation System is explicitly intended for single-use in orthopedic surgical settings. This ensures sterility and reduces the risk of cross-contamination between patients.

  • How is the Prophecy Invision Pre-operative Navigation System supplied, and what does the sterile packaging include?

    The system is supplied as a sterile, pre-packaged kit, ready for immediate use in the operating room. The sterile packaging ensures all components are protected and ready for single-use procedures.

  • What regulatory pathway was followed for FDA clearance of the Prophecy Invision Pre-operative Navigation System?

    The Prophecy Invision Pre-operative Navigation System received FDA clearance through a 510(k) submission (K170968) under the traditional review pathway. It is classified as a Class II device under FDA regulation 888.3110 and is intended for use with specific ankle prosthesis systems.

  • Are there specific anatomical landmarks or imaging requirements needed to use the Prophecy Invision Pre-operative Navigation System?

    Yes, the system is designed for use only when necessary anatomical landmarks are identifiable on patient imaging scans. This ensures accurate alignment guidance during pre-operative planning for total ankle arthroplasty.