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Prophecy Inbone Pre-operative Navigation Alignment Guides

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K110360

Overview

The Prophecy Inbone Pre-operative Navigation Alignment Guides are patient-specific surgical guides designed from patient CT imaging data and manufactured from biocompatible nylon. They are intended to assist in positioning total ankle replacement components and marking bone prior to cutting during surgery.

These guides are intended for single use only and are used intra-operatively by surgeons. They are supplied as patient-specific instrumentation and are regulated under FDA 510(k) clearance K110360 with product code HSN and regulation number 888.3110.

AI-generated from registry data, 26 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 NumberK110360 Date16 Dec 2011ClearedStatusActive

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
  • Withdrawn
  • Listed
  • Not known
  • 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 Prophecy Inbone Pre-operative Navigation Alignment Guide used for?

    It is a patient-specific surgical guide designed from CT imaging data to assist surgeons in positioning total ankle replacement components and marking bone prior to cutting during intra-operative procedures.

  • Is the Prophecy Inbone guide reusable or single-use?

    The device is intended for single use only, as stated in the description, and is supplied as patient-specific instrumentation for one-time intra-operative use by surgeons.

  • What material is the Prophecy Inbone guide made from and how is it manufactured?

    The guides are manufactured from biocompatible nylon and are produced based on individual patient CT imaging data to create a customized surgical aid.

  • What regulatory pathway was used for the Prophecy Inbone guide?

    The device received FDA 510(k) clearance under K110360, indicating it was found substantially equivalent to a legally marketed predicate device.

  • What product code and regulation number apply to the Prophecy Inbone guide?

    The device is classified under product code HSN and regulation number 888.3110, as specified in the authorization and device data fields.