510(k) · Cleared
ClearedPROPHECY INVISION Pre-operative Navigation 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 Aug 16, 2017 as substantially equivalent to K162795 (Wrightmedicaltechnologyinc, 2017) and 4 other predicates after a 138-day review. Its family tree reaches back 8 generations to 1992. 16 later devices descend from it.
- Decided
- Aug 16, 2017
- Review
- 138 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K920802 (1992). 14 ancestors in all. 16 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 7 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 6 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 5 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 4 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 3 generations backK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- 2 generations backK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
- 1 generation backK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- This deviceK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 1 of its ownK241999 Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K193432Vantage PSI System3D Systems · 2020 · cites it directly6descendants
- 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
- K241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −7 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −6 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −5 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −4 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −3 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| −2 | K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | 2015 | — |
| −1 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017 | — |
| 0 (this device) | K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017 | — |
| +1 | 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 | — |
| +3 | K241999 | Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2024 | — |
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 |
|---|---|---|
| 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 16.8 · 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? (5)
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 |
|---|---|---|---|
| * | K162795 | PROPHECY INVISION Preoperative Navigation Alignment SystemSummary page 5…anel: HSN, OYK – Orthopedic (a)(3) PREDICATE DEVICE INFORMATION PROPHECY INVISION Pre-operative Navigation Alignment System: K162795 PROPHECY INFINITY Pre-operative Navigation Alignment System: K131283 PROPHECY INBONE Pre-operative N… | 2017 |
| * | K131283 | Prophecy Infinity Preoperative Navigation Alignment GuidesSummary page 5…PROPHECY INVISION Pre-operative Navigation Alignment System: K162795 PROPHECY INFINITY Pre-operative Navigation Alignment System: K131283 PROPHECY INBONE Pre-operative Navigation Alignment System: K110360 INVISION Total Ankle System:… | 2013 |
| * | K110360 | Prophecy Inbone Pre-Operative Navigation Alignment GuidesSummary page 5…PROPHECY INFINITY Pre-operative Navigation Alignment System: K131283 PROPHECY INBONE Pre-operative Navigation Alignment System: K110360 INVISION Total Ankle System: K142117, K153008… | 2011 |
| * | K142117 | Invision Total Ankle Revision SystemSummary page 5…PROPHECY INBONE Pre-operative Navigation Alignment System: K110360 INVISION Total Ankle System: K142117, K153008 Attachment 6 Page 1 of 3 =… | 2015 |
| * | K153008 | INVISION Total Ankle Revision SystemSummary page 5…PHECY INBONE Pre-operative Navigation Alignment System: K110360 INVISION Total Ankle System: K142117, K153008 Attachment 6 Page 1 of 3 === Page 6… | 2016 |
What descends from it? (16)
See all 164 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 14 ancestors have a recall of any class.
- Of its descendants, K193432 (3D Systems, 2020) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K162795.
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™, INFINITY™, and INVISION™ Total Ankle Systems and their cleared indications for use, provided…
Read the full statement (132 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™, 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. 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/K170968 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170968: PROPHECY INVISION Pre-operative Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170968
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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