510(k) · Cleared
ClearedINVISION Total Ankle Revision 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 May 6, 2016 as substantially equivalent to K140749 (Wrightmedicaltechnologyinc, 2014) and 5 other predicates after a 205-day review. Its family tree reaches back 6 generations to 1992. 29 later devices descend from it.
- Decided
- May 6, 2016
- Review
- 205 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K920802 (1992). 9 ancestors in all. 29 later devices descend from it, 4 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 backK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- This deviceK153008 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016
- Descendant · cites it directly · 17 of its ownK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- Descendant · cites it directly · 16 of its ownK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- Descendant · cites it directly · 13 of its ownK171067 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017
- Descendant · 2 generations on · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK193432 Vantage PSI System3D Systems · 2020
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017 · cites it directly17descendants
- K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017 · cites it directly16descendants
- K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017 · cites it directly13descendants
- K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020 · 2 generations on8descendants
- K193432Vantage PSI System3D Systems · 2020 · 2 generations on6descendants
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 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| 0 (this device) | K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2016 | — |
| +1 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017 | — |
| +1 | K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017 | — |
| +1 | K171067 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2017 | — |
| +2 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | — |
| +2 | K193432 | Vantage PSI System | 3D Systems | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K140749 | Infinity Total Ankle SystemSummary page 5…ame and Reference: 21 CFR 888.3110- Class II Device Product Code, Device Panel: HSN - Orthopedic 3. Predicate Device: K140749 INFINITY® Total Ankle System K123954 INFINITY® Total Ankle System… | 2014 |
| * | K123954 | Infinity Total Ankle SystemSummary page 5…de, Device Panel: HSN - Orthopedic 3. Predicate Device: K140749 INFINITY® Total Ankle System K123954 INFINITY® Total Ankle System K133585 INBONE® II Total Ankle System… | 2013 |
| * | K133585 | Inbone Total AnkleSummary page 5…K140749 INFINITY® Total Ankle System K123954 INFINITY® Total Ankle System K133585 INBONE® II Total Ankle System K100886 INBONE® II Total Ankle System… | 2014 |
| * | K100886 | Inbone II Total Ankle ReplacementSummary page 5…K123954 INFINITY® Total Ankle System K133585 INBONE® II Total Ankle System K100886 INBONE® II Total Ankle System K103374 INBONE® II Total Ankle System… | 2010 |
| * | K103374 | Inbone Total Ankle System Model 200347902Summary page 5…K133585 INBONE® II Total Ankle System K100886 INBONE® II Total Ankle System K103374 INBONE® II Total Ankle System K051023 INBONE® II Total Ankle System 4. Device De… | 2010 |
| * | K051023 | Topez Total Ankle ReplacementSummary page 5…K100886 INBONE® II Total Ankle System K103374 INBONE® II Total Ankle System K051023 INBONE® II Total Ankle System 4. Device Description The subject INVISION® Total Ankle Revision System is a fixed-be… | 2005 |
What descends from it? (29)
See all 294 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 24 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K162795 (Wrightmedicaltechnologyinc, 2017) has gone furthest, with 17 descendants of its own.
- 8 other devices also cite its predicate K140749.
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 INVISION® Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INVISION® Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153008: INVISION Total Ankle Revision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153008
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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