510(k) · Cleared
ClearedProphecy Preoperative Navigation Alignment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jan 27, 2023 as substantially equivalent to K202815 (Wrightmedicaltechnologyinc, 2021) after a 129-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- Jan 27, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K920802 (1992). 16 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 6 generations between
- 3 generations backK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- 2 generations backK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- 1 generation backK202815 PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
- This deviceK222835 Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
- Descendant · cites it directly · 1 of its ownK241999 Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2024
- Descendant · 2 generations on · 0 of its ownK253159 Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2026
Show all 10 generations
- Root · 10 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 9 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 8 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 7 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 6 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 5 generations backK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- 4 generations backK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
- 3 generations backK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- 2 generations backK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- 1 generation backK202815 PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
- This deviceK222835 Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −9 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −8 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −7 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −6 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −5 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| −4 | K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | 2015 | — |
| −3 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017 | — |
| −2 | K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017 | — |
| −1 | K202815 | PROPHECY Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2021 | — |
| 0 (this device) | K222835 | Prophecy Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2023 | — |
| +1 | K241999 | Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2024 | — |
| +2 | K253159 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
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 K192994 Paragon 28 APEX 3D Total Ankle Replacement…score 16.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202815 | PROPHECY Preoperative Navigation Alignment SystemSummary page 4…Surgical Planning and Instrument Guides Device Product Code, Device Panel: HSN, OYK, PBF (a)(3). Primary Predicate Device: K202815 – Prophecy® Preoperative Navigation Alignment System Refe… | 2021 |
| † | K203315 | BLUEPRINT™ Patient Specific Instrumentation | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241999 | Prophecy Surgical Planning System | 2024 | 1 |
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 31 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K241999 (Wright Medical Technology, Inc. (Stryker), 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K202815.
How does its category compare?
All HSN devicesHSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HSN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSN
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSN
1,645in 2025
MAUDE reports naming product code HSN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 50 |
| 2008 | 0 | — | 0 | 66 |
| 2009 | 1 | — | 0 | 66 |
| 2010 | 2 | — | 0 | 120 |
| 2011 | 1 | — | 0 | 139 |
| 2012 | 2 | — | 0 | 100 |
| 2013 | 4 | 89 | 3 | 106 |
| 2014 | 2 | — | 0 | 65 |
| 2015 | 3 | 233 | 0 | 73 |
| 2016 | 3 | 216 | 1 | 111 |
| 2017 | 4 | 148 | 2 | 96 |
| 2018 | 4 | 89 | 0 | 187 |
| 2019 | 2 | — | 1 | 277 |
| 2020 | 6 | 234 | 0 | 281 |
| 2021 | 4 | 109 | 3 | 237 |
| 2022 | 1 | — | 2 | 453 |
| 2023 | 6 | 112 | 1 | 796 |
| 2024 | 7 | 115 | 0 | 1,095 |
| 2025 | 3 | 58 | 0 | 1,645 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The 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, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Preoperative Navigation Alignment Guides and Reports are intended for use with the…
Read the full statement (109 words)
The 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, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Preoperative Navigation Alignment Guides and Reports are intended for use with the lnbone®, 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. The Prophecy® Preoperative Navigation Alignment Guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222835: Prophecy Preoperative Navigation Alignment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222835
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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