510(k) · Cleared
ClearedInbone Total Ankle System Model 200347902
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 Dec 14, 2010 after a 27-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 54 later devices descend from it.
- Decided
- Dec 14, 2010
- Review
- 27 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 1
54 later devices descend from it, 4 citing it directly.
- This deviceK103374 Inbone Total Ankle System Model 200347902Wrightmedicaltechnologyinc · 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 · 2 generations on · 34 of its ownK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 29 of its ownK153008 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016
- Descendant · 2 generations on · 29 of its ownK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · cites it directly52descendants
- K140749Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · 2 generations on48descendants
- K133585Inbone Total AnkleWrightmedicaltechnologyinc · 2014 · 2 generations on34descendants
- K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016 · cites it directly29descendants
- K142117Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K103374 | Inbone Total Ankle System Model 200347902 | Wrightmedicaltechnologyinc | 2010 | — |
| +1 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| +2 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| +2 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2016 | — |
| +2 | 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 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K085102 | INBONE Total Ankle System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (54)
See all 544 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?
- Of its descendants, K123954 (Wrightmedicaltechnologyinc, 2013) has gone furthest, with 52 descendants of its own.
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?
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The ankle prosthesis 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/K103374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103374: Inbone Total Ankle System Model 200347902.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103374
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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