510(k) Report

510(k) · Cleared

Cleared

Prophecy Inbone Pre-Operative Navigation Alignment Guides

K110360510(k) TraditionalCleared Dec 16, 2011311-day reviewClass II21 CFR 888.3110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Dec 16, 2011 as substantially equivalent to K051023 (Topez Orthopedics, Inc., 2005) after a 311-day review. Its family tree reaches back 3 generations to 1992. 19 later devices descend from it.

Decided
Dec 16, 2011
Review
311 days
Class
Class II
Product code
HSN
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K920802 (1992). 19 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2021: 3 descendants cleared2017: 2 descendants cleared2026: 1 descendant cleared2020: 1 descendant cleared2023: 4 descendants cleared2024: 6 descendants cleared2022: 1 descendant clearedK920802 · Alvine Total Ankle · Depuy, Inc. · 1992K020541 · Agility Ankle Revision Prosthesis · Depuy, Inc. · 2002K051023 · Topez Total Ankle Replacement · Topez Orthopedics, Inc. · 2005 · recalled1990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 8 descendants4 generations forward: 2 descendants K051023 · Topez Total Ankle Replacement · Topez Orthopedics, Inc. · 2005 · recalledK020541 · Agility Ankle Revision Prosthesis · Depuy, Inc. · 2002K920802 · Alvine Total Ankle · Depuy, Inc. · 19920
  1. Root · 3 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
  2. 2 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
  3. 1 generation backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
  4. This deviceK110360 Prophecy Inbone Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2011
  5. Descendant · cites it directly · 18 of its ownK131283 Prophecy Infinity Preoperative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2013
  6. Descendant · cites it directly · 17 of its ownK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
  7. Descendant · cites it directly · 16 of its ownK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
  8. Descendant · 2 generations on · 6 of its ownK193432 Vantage PSI System3D Systems · 2020
  9. Descendant · cites it directly · 3 of its ownK202815 PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2013: 12017: 22020: 12021: 32022: 12023: 42024: 62026: 1
2013high 6 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 19 · See all
  • K131283Prophecy Infinity Preoperative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2013 · cites it directly18descendants
  • K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017 · cites it directly17descendants
  • K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017 · cites it directly16descendants
  • K193432Vantage PSI System3D Systems · 2020 · 2 generations on6descendants
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K920802Alvine Total AnkleDepuy, Inc.1992—
−2K020541Agility Ankle Revision ProsthesisDepuy, Inc.2002—
−1K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc.20054
0 (this device)K110360Prophecy Inbone Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc2011—
+1K131283Prophecy Infinity Preoperative Navigation Alignment GuidesWrightmedicaltechnologyinc2013—
+1K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc2017—
+1K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc2017—
+2K193432Vantage PSI System3D Systems2020—
+1K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201720
202010
202130
202210
202340
202460
202610
FIG. 1 — Lineage of K110360, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HSN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HSN device

  1. #1 K192994 Paragon 28 APEX 3D Total Ankle Replacement…score 16.7 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc.20054

Also cleared against K051023: 8 other devices →

What descends from it? (19)

See all 19

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131283Prophecy Infinity Preoperative Navigation Alignment GuidesWrightmedicaltechnologyinc201318
K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc201717
K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc201716
K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc20213

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K131283 (Wrightmedicaltechnologyinc, 2013) has gone furthest, with 18 descendants of its own.
  • 8 other devices also cite its predicate K051023.

How does its category compare?

All HSN devices

HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HSN

3in 2025

2009: 12010: 22011: 12012: 22013: 42014: 22015: 32016: 32017: 42018: 42019: 22020: 62021: 42022: 12023: 62024: 72025: 32026 (partial year): 2
2007high 7 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSN

58in 2025

2013: 89 days median2015: 233 days median2016: 216 days median2017: 148 days median2018: 89 days median2020: 234 days median2021: 109 days median2023: 112 days median2024: 115 days median2025: 58 days median
2007high 234 (2020) · low 58 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSN

1in 2023

2013: 32016: 12017: 22019: 12021: 32022: 22023: 1
2007high 3 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSN

1,645in 2025

2007: 502008: 662009: 662010: 1202011: 1392012: 1002013: 1062014: 652015: 732016: 1112017: 962018: 1872019: 2772020: 2812021: 2372022: 4532023: 7962024: 1,0952025: 1,645
2007high 1,645 (2025) · low 50 (2007)2025

MAUDE reports naming product code HSN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—050
20080—066
20091—066
20102—0120
20111—0139
20122—0100
20134893106
20142—065
20153233073
201632161111
20174148296
20184890187
20192—1277
202062340281
202141093237
20221—2453
202361121796
2024711501,095
202535801,645
20262—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K051023

8 other devices cite the same predicate.

  • K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017
  • K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016
  • K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 201319 recalls
  • K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc · 20132 recalls
  • K123059Inbone ( I and II) Total Ankle SystemsWrightmedicaltechnologyinc · 2013
  • K100886Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 20102 recalls

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

Recent decisions in HSN

The HSN category page

  • K261120APEX 3D S Diamond TibiaParagon 28, Inc. · 2026
  • K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2026
  • K252454Kinos Total Ankle SystemRestor3D · 2025
  • K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker) · 2025
  • K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2025

https://510kreport.com/device/K110360 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110360: Prophecy Inbone Pre-Operative Navigation Alignment Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110360

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026