510(k) · Cleared
Recalled · Class II · 2021Inbone II Total Ankle Replacement
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 26, 2010 as substantially equivalent to K051023 (Topez Orthopedics, Inc., 2005) after a 149-day review. Its family tree reaches back 3 generations to 1992. 56 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 26, 2010
- Review
- 149 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920802 (1992). 56 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 2 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 1 generation backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- This deviceK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010
- Descendant · cites it directly · 52 of its ownK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- Descendant · 2 generations on · 48 of its ownK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
- Descendant · cites it directly · 34 of its ownK133585 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
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · cites it directly52descendants
- K140749Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · 2 generations on48descendants
- K133585Inbone Total AnkleWrightmedicaltechnologyinc · 2014 · cites it directly34descendants
- K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016 · cites it directly29descendants
- K142117Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015 · cites it directly29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −2 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −1 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| 0 (this device) | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | — |
| +1 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| +2 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| +1 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2016 | — |
| +1 | K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 9 | 0 |
| 2024 | 12 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K051023 | Topez Total Ankle Replacement | 2005 |
What descends from it? (56)
See all 568 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123954 | Infinity Total Ankle System | 2013 | 52 |
| K133585 | Inbone Total Ankle | 2014 | 34 |
| K153008 | INVISION Total Ankle Revision System | 2016 | 29 |
| K142117 | Invision Total Ankle Revision System | 2015 | 29 |
| K123059 | Inbone ( I and II) Total Ankle Systems | 2013 | 21 |
| K151459 | Integra Total Ankle Replacement System | 2015 | 14 |
| 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2021 | Class II | Z-0315-2022 | Nonconforming Material/Component | The package contents and package labeling do not match. |
| Nov 4, 2021 | Class II | Z-0316-2022 | Nonconforming Material/Component | The package contents and package labeling do not match. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K123954 (Wrightmedicaltechnologyinc, 2013) has gone furthest, with 52 descendants of its own.
- 8 other devices also cite its predicate K051023.
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. 2010, 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 INBONETm Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONETm Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100886: Inbone II Total Ankle Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100886
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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