510(k) · Cleared
Recalled · Class II · 2024Infinity 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 1, 2013 as substantially equivalent to K051023 (Topez Orthopedics, Inc., 2005) and 3 other predicates after a 101-day review. Its family tree reaches back 4 generations to 1992. 52 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 1, 2013
- Review
- 101 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 4 generations to K920802 (1992). 6 ancestors in all. 52 later devices descend from it, 11 citing it directly.
- Root · 4 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 3 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 2 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 1 generation backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- This deviceK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013
- Descendant · cites it directly · 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
- Descendant · cites it directly · 18 of its ownK131283 Prophecy Infinity Preoperative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2013
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K140749Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · cites it directly48descendants
- 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
- K131283Prophecy Infinity Preoperative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2013 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −3 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −2 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −1 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| 0 (this device) | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | — |
| +1 | 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 | — |
| +1 | K131283 | Prophecy Infinity Preoperative Navigation Alignment Guides | Wrightmedicaltechnologyinc | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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? (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 |
|---|---|---|---|
| * | K051023 | Topez Total Ankle ReplacementSummary page 1…21 CFR 888.3110 -Class 11 Device Product Code, Device Panel: HSN: Orthopedic 3. Predicate Devices: K05 1023 - INBONE® Total Ankle System K053569 - DePuy AgilityTM Total Ankle… | 2005 |
| * | K053569 | Agility LP Total Ankle ProsthesisSummary page 1…opedic 3. Predicate Devices: K05 1023 - INBONE® Total Ankle System K053569 - DePuy AgilityTM Total Ankle Prosthesis K 100886 - NBONE® 11 Total… | 2006 |
| * | K100886 | Inbone II Total Ankle ReplacementSummary page 1…K053569 - DePuy AgilityTM Total Ankle Prosthesis K 100886 - NBONE® 11 Total Ankle System K 103374 - [NBONE® Total Ankle Syste… | 2010 |
| * | K103374 | Inbone Total Ankle System Model 200347902Summary page 1…hesis K 100886 - NBONE® 11 Total Ankle System K 103374 - [NBONE® Total Ankle System 4. Device Description The INFINITYTm Total Ankle System is a fixed-bearing total ankl… | 2010 |
What descends from it? (52)
See all 5211 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140749 | Infinity Total Ankle System | 2014 | 48 |
| K133585 | Inbone Total Ankle | 2014 | 34 |
| K153008 | INVISION Total Ankle Revision System | 2016 | 29 |
| K142117 | Invision Total Ankle Revision System | 2015 | 29 |
| K131283 | Prophecy Infinity Preoperative Navigation Alignment Guides | 2013 | 18 |
| K141740 | Infinity (TM) Total Ankle System; Inbone Total Ankle System | 2015 | 17 |
| K152217 | Exactech Vantage Total Ankle System | 2016 | 7 |
| K192778 | Kinos Axiom Total Ankle System | 2020 | 5 |
| K172633 | INFINITY Total Ankle System | 2018 | 2 |
| K240591 | restor3d Kinos Axiom Total Ankle System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2024 | Class II | Z-1477-2024 | Process change control | Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The… |
| Jun 13, 2023 | Class II | Z-2105-2023 | Process control | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K140749 (Wrightmedicaltechnologyinc, 2014) has gone furthest, with 48 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. 2013, 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 is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INFINITY™ 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/K123954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123954: 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/K123954
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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