510(k) · Cleared
Recalled · Class II · 2023Exactech Vantage Total Ankle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Mar 10, 2016 as substantially equivalent to K090076 (Tornier, 2009) and 2 other predicates after a 216-day review. Its family tree reaches back 6 generations to 1992. 7 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 10, 2016
- Review
- 216 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 6 generations to K920802 (1992). 10 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 5 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 4 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 3 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 2 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 1 generation backK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
- This deviceK152217 Exactech Vantage Total Ankle SystemExactech, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK171004 Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK240475 Hintermann Series H2 Total Ankle SystemVilex, LLC · 2024
- Descendant · cites it directly · 0 of its ownK230717 Exactech® Vantage® Total Ankle SystemExactech, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK232002 Vantage® Total Ankle SystemExactech, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK230462 OPTIX H2 Patient Specific Instrument SystemVilex, LLC · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017 · cites it directly2descendants
- K240475Hintermann Series H2 Total Ankle SystemVilex, LLC · 2024 · 2 generations on0descendants
- K230717Exactech® Vantage® Total Ankle SystemExactech, Inc. · 2023 · cites it directly0descendants
- K232002Vantage® Total Ankle SystemExactech, Inc. · 2023 · cites it directly0descendants
- K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −5 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −4 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −3 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −2 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −1 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| 0 (this device) | K152217 | Exactech Vantage Total Ankle System | Exactech, Inc. | 2016 | — |
| +1 | K171004 | Hintermann Series H2 Total Ankle System | Dt Medtech, LLC | 2017 | — |
| +2 | K240475 | Hintermann Series H2 Total Ankle System | Vilex, LLC | 2024 | — |
| +1 | K230717 | Exactech® Vantage® Total Ankle System | Exactech, Inc. | 2023 | — |
| +1 | K232002 | Vantage® Total Ankle System | Exactech, Inc. | 2023 | — |
| +2 | K230462 | OPTIX H2 Patient Specific Instrument System | Vilex, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K090076 | Salto Talaris Total Ankle ProsthesisSummary page 4…Class II Product Code: HSN Legally Marketed Device to Which Substantial Equivalence Is Claime d: Salto Talaris™ Total Ankle Prosthesis (K090076) from Tornier INFINITY® Total Ankle System (K123954, and K140749 - line extension to devices cleared in K123954) from… | 2009 |
| * | K123954 | Infinity Total Ankle SystemSummary page 4…egally Marketed Device to Which Substantial Equivalence Is Claime d: Salto Talaris™ Total Ankle Prosthesis (K090076) from Tornier INFINITY® Total Ankle System (K123954, and K140749 - line extension to devices cleared in K123954) from Wright Medical Technology, Inc. Device Description Exac… | 2013 |
| * | K140749 | Infinity Total Ankle SystemSummary page 4…ed Device to Which Substantial Equivalence Is Claime d: Salto Talaris™ Total Ankle Prosthesis (K090076) from Tornier INFINITY® Total Ankle System (K123954, and K140749 - line extension to devices cleared in K123954) from Wright Medical Technology, Inc. Device Description Exactech Vantage… | 2014 |
What descends from it? (7)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2023 | Class II | Z-0587-2024 | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Aug 30, 2021 | Class II | Z-0024-2022 | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Aug 10, 2020 | Class II | Z-2926-2020 | Error in labeling | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have… |
| Jul 13, 2018 | Class II | Z-2966-2018 | Employee error | Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628. |
| May 16, 2017 | Class II | Z-0200-2018 | Under Investigation by firm | Possible inner labeling and packaged device not matching the outer label on the box. |
| May 16, 2017 | Class II | Z-0201-2018 | Under Investigation by firm | Possible inner labeling and packaged device not matching the outer label on the box. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K171004 (Dt Medtech, LLC, 2017) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K090076.
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. 2016, 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 Vantage™ Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The Vantage™ Total Ankle System is indicated for cemented use only.
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/K152217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152217: Exactech Vantage Total Ankle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152217
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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