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 Aug 9, 2018 as substantially equivalent to K123954 (Wrightmedicaltechnologyinc, 2013) and 3 other predicates after a 57-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Aug 9, 2018
- Review
- 57 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K911686 (1991). 39 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations between
- 3 generations backK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- 2 generations backK161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016 · Recalled
- 1 generation backK172633 INFINITY Total Ankle SystemWrightmedicaltechnologyinc · 2018
- This deviceK181557 INFINITY Total Ankle SystemWrightmedicaltechnologyinc · 2018
Show all 11 generations
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 9 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 8 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 7 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 4 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 3 generations backK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- 2 generations backK161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016 · Recalled
- 1 generation backK172633 INFINITY Total Ankle SystemWrightmedicaltechnologyinc · 2018
- This deviceK181557 INFINITY Total Ankle SystemWrightmedicaltechnologyinc · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −10 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −7 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −4 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −3 | K081059 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2008 | — |
| −2 | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | Tornier, Inc. | 2016 | 3 |
| −1 | K172633 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018 | — |
| 0 (this device) | 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 |
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? (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 4…21 CFR 888.3110 - Class II Device Product Code, Device Panel: HSN – Orthopedic (a)(3). Predicate Device: K123954, K140749, K172633 –INFINITY Total Ankle System… | 2013 |
| * | K140749 | Infinity Total Ankle SystemSummary page 4…CFR 888.3110 - Class II Device Product Code, Device Panel: HSN – Orthopedic (a)(3). Predicate Device: K123954, K140749, K172633 –INFINITY Total Ankle System… | 2014 |
| * | K172633 | INFINITY Total Ankle SystemSummary page 4…110 - Class II Device Product Code, Device Panel: HSN – Orthopedic (a)(3). Predicate Device: K123954, K140749, K172633 –INFINITY Total Ankle System… | 2018 |
| * | K141740 | Infinity (TM) Total Ankle System; Inbone Total Ankle SystemSummary page 4…3954, K140749, K172633 –INFINITY Total Ankle System K141740 - INBONE and INFINITY Total Ankle Systems (a)(4). Device Description… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 1.3 years on median.
- 6 of the 39 ancestors have a recall of any class.
- 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/K181557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181557: INFINITY 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/K181557
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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