510(k) · Cleared
ClearedINFINITY Total Ankle 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 Apr 26, 2018 as substantially equivalent to K123954 (Wrightmedicaltechnologyinc, 2013) and 3 other predicates after a 237-day review. Its family tree reaches back 10 generations to 1991. 2 later devices descend from it.
- Decided
- Apr 26, 2018
- Review
- 237 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K911686 (1991). 38 ancestors in all, the oldest K800494 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations between
- 3 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 2 generations backK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- 1 generation backK161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016 · Recalled
- This deviceK172633 INFINITY Total Ankle SystemWrightmedicaltechnologyinc · 2018
- Descendant · cites it directly · 0 of its ownK191393 INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc · 2019
- Descendant · cites it directly · 0 of its ownK181557 INFINITY Total Ankle SystemWrightmedicaltechnologyinc · 2018
Show all 10 generations
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 8 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 7 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 6 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 4 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 3 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 2 generations backK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- 1 generation backK161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016 · Recalled
- This deviceK172633 INFINITY Total Ankle SystemWrightmedicaltechnologyinc · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −9 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −6 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −4 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −3 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −2 | K081059 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2008 | — |
| −1 | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | Tornier, Inc. | 2016 | 3 |
| 0 (this device) | K172633 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018 | — |
| +1 | K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc | 2019 | — |
| +1 | K181557 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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? (4)
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 5…21 CFR 888.3110 - Class II Device Product Code, Device Panel: HSN – Orthopedic (a)(3). Predicate Device: K123954, K140749 –INFINITY Total Ankle System… | 2013 |
| * | K140749 | Infinity Total Ankle SystemSummary page 5…CFR 888.3110 - Class II Device Product Code, Device Panel: HSN – Orthopedic (a)(3). Predicate Device: K123954, K140749 –INFINITY Total Ankle System… | 2014 |
| * | K141740 | Infinity (TM) Total Ankle System; Inbone Total Ankle SystemSummary page 5…K123954, K140749 –INFINITY Total Ankle System K141740 - INBONE and INFINITY Total Ankle Systems… | 2015 |
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 5…K141740 - INBONE and INFINITY Total Ankle Systems K161742- Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid (a)(4)… | 2016 |
What descends from it? (2)
2 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 27 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 38 ancestors have a recall of any class.
- Of its descendants, K191393 (Wrightmedicaltechnologyinc, 2019) has gone furthest, with 0 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. 2018, 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 INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INFINITY Total Ankle 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/K172633 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172633: INFINITY Total Ankle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172633
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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