510(k) · Cleared
ClearedIncompass Total Ankle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wright Medical Technology, Inc. (Stryker) · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jun 20, 2025 as substantially equivalent to K193067 (Wrightmedicaltechnologyinc, 2020) after a 163-day review. Its family tree reaches back 10 generations to 1992. 1 later device descends from it.
- Decided
- Jun 20, 2025
- Review
- 163 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K920802 (1992). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 6 generations between
- 3 generations backK171067 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017
- 2 generations backK180730 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2018
- 1 generation backK193067 The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and…Wrightmedicaltechnologyinc · 2020
- This deviceK250037 Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker) · 2025
- Descendant · cites it directly · 0 of its ownK253159 Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2026
Show all 10 generations
- Root · 10 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 9 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 8 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 7 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 6 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 5 generations backK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
- 4 generations backK141740 Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc · 2015
- 3 generations backK171067 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017
- 2 generations backK180730 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2018
- 1 generation backK193067 The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and…Wrightmedicaltechnologyinc · 2020
- This deviceK250037 Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker) · 2025
Most influential descendants
Showing 1 of 1 · See all- K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −9 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −8 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −7 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −6 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −5 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| −4 | K141740 | Infinity (TM) Total Ankle System; Inbone Total Ankle System | Wrightmedicaltechnologyinc | 2015 | — |
| −3 | K171067 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2017 | — |
| −2 | K180730 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2018 | — |
| −1 | K193067 | The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the… | Wrightmedicaltechnologyinc | 2020 | — |
| 0 (this device) | K250037 | Incompass Total Ankle System | Wright Medical Technology, Inc. (Stryker) | 2025 | — |
| +1 | K253159 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K193067 | The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total…Summary page 5…Total Ankle System and the Invision Total Ankle Revision System (K193067) (a)(4). Reference Predicate Device(s): Infinity Total Ankle System (K191393, K181557,… | 2020 |
| * | — | Inbone Total Ankle System Named without a submission number | |
| * | — | Infinity Total Ankle System Named without a submission number | |
| † | K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | 2019 |
| † | K181557 | INFINITY Total Ankle System | 2018 |
| † | K172633 | INFINITY Total Ankle System | 2018 |
| † | K140749 | Infinity Total Ankle System | 2014 |
| † | K123954 | Infinity Total Ankle System | 2013 |
| † | K133585 | Inbone Total Ankle | 2014 |
| † | K123059 | Inbone ( I and II) Total Ankle Systems | 2013 |
| † | K110360 | Prophecy Inbone Pre-Operative Navigation Alignment Guides | 2011 |
| † | K100886 | Inbone II Total Ankle Replacement | 2010 |
| † | K051023 | Topez Total Ankle Replacement | 2005 |
| † | K053569 | Agility LP Total Ankle Prosthesis | 2006 |
| † | K222510 | Blueprint Mixed Reality system | 2023 |
| † | K201315 | PERFORM Humeral System – Stem | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253159 | Prophecy Incompass Surgical Planning System | 2026 | 0 |
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 33 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K253159 (Wright Medical Technology, Inc. (Stryker), 2026) has gone furthest, with 0 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. 2025, 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?
Intended Use:
The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Indications for Use:
The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The Incompass Total Ankle 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250037: Incompass 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/K250037
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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