510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Infinity Total Ankle System

K140749510(k) SpecialCleared Apr 25, 201431-day reviewClass II21 CFR 888.3110Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Apr 25, 2014 as substantially equivalent to K123954 (Wrightmedicaltechnologyinc, 2013) after a 31-day review. Its family tree reaches back 5 generations to 1992. 48 later devices descend from it. It has been recalled once.

Decided
Apr 25, 2014
Review
31 days
Class
Class II
Product code
HSN
Recalls
1
Predicates
1

Its longest line of descent runs back 5 generations to K920802 (1992). 7 ancestors in all. 48 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2006: 1 other ancestor2016: 2 descendants cleared2015: 2 descendants cleared2020: 6 descendants cleared2018: 3 descendants cleared2023: 9 descendants cleared2017: 4 descendants cleared2019: 2 descendants cleared2025: 3 descendants cleared2024: 11 descendants cleared2021: 4 descendants cleared2026: 1 descendant cleared2022: 1 descendant clearedK920802 · Alvine Total Ankle · Depuy, Inc. · 1992K020541 · Agility Ankle Revision Prosthesis · Depuy, Inc. · 2002K051023 · Topez Total Ankle Replacement · Topez Orthopedics, Inc. · 2005 · recalledK100886 · Inbone II Total Ankle Replacement · Wrightmedicaltechnologyinc · 2010 · recalledK123954 · Infinity Total Ankle System · Wrightmedicaltechnologyinc · 2013 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 9 descendants2 generations forward: 13 descendants3 generations forward: 9 descendants4 generations forward: 12 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant K123954 · Infinity Total Ankle System · Wrightmedicaltechnologyinc · 2013 · recalledK100886 · Inbone II Total Ankle Replacement · Wrightmedicaltechnologyinc · 2010 · recalledK051023 · Topez Total Ankle Replacement · Topez Orthopedics, Inc. · 2005 · recalledK020541 · Agility Ankle Revision Prosthesis · Depuy, Inc. · 2002K920802 · Alvine Total Ankle · Depuy, Inc. · 1992−50+5
  1. Root · 5 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
  2. 4 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
  3. 3 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
  4. 2 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
  5. 1 generation backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
  6. This deviceK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014
  7. Descendant · cites it directly · 29 of its ownK153008 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016
  8. Descendant · cites it directly · 29 of its ownK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
  9. Descendant · 2 generations on · 17 of its ownK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
  10. Descendant · cites it directly · 17 of its ownK141740 Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc · 2015
  11. Descendant · 2 generations on · 16 of its ownK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2015: 22016: 22017: 42018: 32019: 22020: 62021: 42022: 12023: 92024: 112025: 32026: 1
2015high 11 (2024) · low 1 (2022)2026

Most influential descendants

Showing 5 of 48 · See all
  • K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016 · cites it directly29descendants
  • K142117Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015 · cites it directly29descendants
  • K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017 · 2 generations on17descendants
  • K141740Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc · 2015 · cites it directly17descendants
  • K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K920802Alvine Total AnkleDepuy, Inc.1992—
−4K020541Agility Ankle Revision ProsthesisDepuy, Inc.2002—
−3K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc.20054
−2K100886Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc20102
−1K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc20132
0 (this device)K140749Infinity Total Ankle SystemWrightmedicaltechnologyinc2014—
+1K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc2016—
+1K142117Invision Total Ankle Revision SystemWrightmedicaltechnologyinc2015—
+2K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc2017—
+1K141740Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc2015—
+2K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201620
201740
201830
201920
202060
202140
202210
202390
2024110
202530
202610
FIG. 1 — Lineage of K140749, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192994 Paragon 28 APEX 3D Total Ankle Replacement…score 16.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K123954Infinity Total Ankle System
Summary page 1
…: 21 CFR 888.3110 - Class 11 Device Product Code, Device Panel: HSN: Ankle Prosthesis (a)(3). Predicate Device: K 123954 INFINITY®D Total Ankle System (a)(4). Device Description The INFINITY® Total Anile System is a fixed-bearing, bone-sparing to…
Wrightmedicaltechnologyinc20132

Also cleared against K123954: 10 other devices →

What descends from it? (48)

See all 48

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc201629
K142117Invision Total Ankle Revision SystemWrightmedicaltechnologyinc201529
K141740Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc201517
K152217Exactech Vantage Total Ankle SystemExactech, Inc.20167
K192778Kinos Axiom Total Ankle SystemKinos Medical20205
K232595Kinos Axiom Total Ankle SystemRestor3D20233
K193067The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total…Wrightmedicaltechnologyinc20202
K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182
K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 2, 2022Class IIZ-1291-2022Nonconforming Material/ComponentThe instrument is incorrectly color coded.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • 3 of the 7 ancestors have a recall of any class.
  • Of its descendants, K153008 (Wrightmedicaltechnologyinc, 2016) has gone furthest, with 29 descendants of its own.
  • 10 other devices also cite its predicate K123954.

How does its category compare?

All HSN devices

HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · HSN

3in 2025

2009: 12010: 22011: 12012: 22013: 42014: 22015: 32016: 32017: 42018: 42019: 22020: 62021: 42022: 12023: 62024: 72025: 32026 (partial year): 2
2007high 7 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSN

58in 2025

2013: 89 days median2015: 233 days median2016: 216 days median2017: 148 days median2018: 89 days median2020: 234 days median2021: 109 days median2023: 112 days median2024: 115 days median2025: 58 days median
2007high 234 (2020) · low 58 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSN

1in 2023

2013: 32016: 12017: 22019: 12021: 32022: 22023: 1
2007high 3 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSN

1,645in 2025

2007: 502008: 662009: 662010: 1202011: 1392012: 1002013: 1062014: 652015: 732016: 1112017: 962018: 1872019: 2772020: 2812021: 2372022: 4532023: 7962024: 1,0952025: 1,645
2007high 1,645 (2025) · low 50 (2007)2025

MAUDE reports naming product code HSN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—050
20080—066
20091—066
20102—0120
20111—0139
20122—0100
20134893106
20142—065
20153233073
201632161111
20174148296
20184890187
20192—1277
202062340281
202141093237
20221—2453
202361121796
2024711501,095
202535801,645
20262—0—

What is it indicated for?

The INFINITYTM Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INFINITYTM Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The ankle prosthesis is intended for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K123954

10 other devices cite the same predicate.

  • K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc. · 2024
  • K192778Kinos Axiom Total Ankle SystemKinos Medical · 2020
  • K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc · 2018
  • K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc · 2018
  • K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016
  • K152217Exactech Vantage Total Ankle SystemExactech, Inc. · 20166 recalls

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

Recent decisions in HSN

The HSN category page

  • K261120APEX 3D S Diamond TibiaParagon 28, Inc. · 2026
  • K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2026
  • K252454Kinos Total Ankle SystemRestor3D · 2025
  • K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker) · 2025
  • K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2025

https://510kreport.com/device/K140749 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140749: Infinity Total Ankle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140749

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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