510(k) · Cleared
ClearedVantage PSI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Systems, Inc. · OYK Ankle Arthroplasty Implantation System
Cleared on Jun 30, 2023 as substantially equivalent to K193432 (3D Systems, 2020) after a 30-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Jun 30, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- OYK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K920802 (1992). 16 ancestors in all. No later device cites it as a predicate yet.
- 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 backK193432 Vantage PSI System3D Systems · 2020
- This deviceK231585 Vantage PSI System3D Systems, Inc. · 2023
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 backK193432 Vantage PSI System3D Systems · 2020
- This deviceK231585 Vantage PSI System3D Systems, Inc. · 2023
View 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 | K193432 | Vantage PSI System | 3D Systems | 2020 | — |
| 0 (this device) | K231585 | Vantage PSI System | 3D Systems, Inc. | 2023 | — |
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 |
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 OYK? 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 OYK device
- #1 K193432 Vantage PSI Systemscore 14.7 · 9 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 |
|---|---|---|---|
| * | K193432 | Vantage PSI SystemSummary page 4…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K193432 11 Vantage PSI System 11 OYK Device D… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 16 ancestors have a recall of any class.
- 3 other devices also cite its predicate K193432.
How does its category compare?
All OYK devicesOYK Ankle Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OYK
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OYK
69in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OYK
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OYK
2in 2025
MAUDE reports naming product code OYK, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 4 | 69 | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intra-operatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231585: Vantage PSI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231585
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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