510(k) · Cleared
ClearedPROPHECY INVISION 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 Feb 22, 2017 as substantially equivalent to K110360 (Wrightmedicaltechnologyinc, 2011) and 3 other predicates after a 141-day review. Its family tree reaches back 7 generations to 1992. 17 later devices descend from it.
- Decided
- Feb 22, 2017
- Review
- 141 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K920802 (1992). 13 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 6 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 5 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 4 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 3 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 2 generations backK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- 1 generation backK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
- This deviceK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- Descendant · cites it directly · 16 of its ownK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- Descendant · 2 generations on · 6 of its ownK193432 Vantage PSI System3D Systems · 2020
- Descendant · cites it directly · 3 of its ownK202815 PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
- Descendant · 2 generations on · 2 of its ownK222835 Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
- Descendant · cites it directly · 2 of its ownK211883 QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- 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
- K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023 · 2 generations on2descendants
- K211883QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2021 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −6 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −5 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −4 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −3 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −2 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| −1 | K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | 2015 | — |
| 0 (this device) | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017 | — |
| +1 | K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017 | — |
| +2 | K193432 | Vantage PSI System | 3D Systems | 2020 | — |
| +1 | K202815 | PROPHECY Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2021 | — |
| +2 | K222835 | Prophecy Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2023 | — |
| +1 | K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2021 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 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 16.7 · 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? (4)
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 |
|---|---|---|---|
| * | K110360 | Prophecy Inbone Pre-Operative Navigation Alignment Guides Our reading of the summary gave K110306, FDA’s number for Sound Surgical Vaser 2.1 Lipo System (Sound Surgical Technologies, LLC). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “PROPHECY® INBONE®”. | 2011 |
| * | K131283 | Prophecy Infinity Preoperative Navigation Alignment GuidesSummary page 4…evice Product Code, Device Panel: HSN, OYK 3. Predicate Device: K110306-PROPHECY® INBONE® K131283-PROPHECY®INFINITY® K142117-INVISION® Total Ankle System… | 2013 |
| * | K142117 | Invision Total Ankle Revision SystemSummary page 4…: K110306-PROPHECY® INBONE® K131283-PROPHECY®INFINITY® K142117-INVISION® Total Ankle System K153008-INVISION® Total Ankle System 4. Device De… | 2015 |
| * | K153008 | INVISION Total Ankle Revision SystemSummary page 4…K131283-PROPHECY®INFINITY® K142117-INVISION® Total Ankle System K153008-INVISION® Total Ankle System 4. Device Description PROPHECY® Preoperative Navigation Alignment System provides the su… | 2016 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K170968 (Wrightmedicaltechnologyinc, 2017) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K110360.
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. 2017, 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?
Wright's 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 and in guiding the marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright’s INBONE® and INFINITY® Total Ankle Systems and their cleared indications for use, provided that anatomic…
Read the full statement (131 words)
Wright's 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 and in guiding the marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright’s INBONE® and INFINITY® 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. The PROPHECY® Preoperative Reports are intended for use with Wright’s INBONE®, 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162795: PROPHECY INVISION Preoperative Navigation Alignment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162795
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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