510(k) · Cleared
ClearedInbone Total Ankle
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 20, 2014 as substantially equivalent to K123954 (Wrightmedicaltechnologyinc, 2013) and 1 other predicate after a 91-day review. Its family tree reaches back 5 generations to 1992. 34 later devices descend from it.
- Decided
- Feb 20, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K920802 (1992). 7 ancestors in all. 34 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 4 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 3 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 2 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 1 generation backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- This deviceK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 29 of its ownK153008 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016
- Descendant · cites it directly · 29 of its ownK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
- Descendant · 2 generations on · 17 of its ownK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- Descendant · 2 generations on · 16 of its ownK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- Descendant · 2 generations on · 13 of its ownK171067 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016 · cites it directly29descendants
- K142117Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015 · cites it directly29descendants
- K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017 · 2 generations on17descendants
- K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017 · 2 generations on16descendants
- K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −4 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −3 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −2 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −1 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| 0 (this device) | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2016 | — |
| +1 | K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | 2015 | — |
| +2 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017 | — |
| +2 | K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017 | — |
| +2 | K171067 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 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 16.8 · 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? (2)
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 |
|---|---|---|---|
| * | K123954 | Infinity Total Ankle SystemSummary page 1…21 CFR 888.3110 -Class 11 Device Product Code, Device Panel: HSN: Ankle Prosthesis [a)(3). Predicate Device: K123954 INFINITY' Total Ankle & K100886 INBONEO 11Total Ankle System (a)(4). De… | 2013 |
| * | K100886 | Inbone II Total Ankle ReplacementSummary page 1…Device Product Code, Device Panel: HSN: Ankle Prosthesis [a)(3). Predicate Device: K123954 INFINITY' Total Ankle & K100886 INBONEO 11Total Ankle System (a)(4). Device Description The INBONE8 i… | 2010 |
What descends from it? (34)
See all 345 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153008 | INVISION Total Ankle Revision System | 2016 | 29 |
| K142117 | Invision Total Ankle Revision System | 2015 | 29 |
| K180730 | INVISION Total Ankle Revision System | 2018 | 3 |
| K193067 | The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total… | 2020 | 2 |
| K171004 | Hintermann Series H2 Total Ankle System | 2017 | 2 |
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 22 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K153008 (Wrightmedicaltechnologyinc, 2016) has gone furthest, with 29 descendants of its own.
- 10 other devices also cite its predicate K123954.
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. 2014, 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 INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE® Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133585: Inbone Total Ankle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133585
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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