510(k) Report

510(k) · Cleared

Cleared

Inbone ( I and II) Total Ankle Systems

K123059510(k) TraditionalCleared Mar 4, 2013154-day reviewClass II21 CFR 888.3110

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 Mar 4, 2013 as substantially equivalent to K051023 (Topez Orthopedics, Inc., 2005) and 2 other predicates after a 154-day review. Its family tree reaches back 4 generations to 1992. 21 later devices descend from it.

Decided
Mar 4, 2013
Review
154 days
Class
Class II
Product code
HSN
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K920802 (1992). 5 ancestors in all. 21 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2017: 2 descendants cleared2019: 1 descendant cleared2015: 1 descendant cleared2018: 3 descendants cleared2023: 2 descendants cleared2024: 3 descendants cleared2020: 3 descendants cleared2021: 2 descendants cleared2025: 2 descendants cleared2022: 1 descendant cleared2026: 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants K100886 · 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. · 19920+5
  1. Root · 4 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
  2. 3 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
  3. 2 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
  4. 1 generation backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
  5. This deviceK123059 Inbone ( I and II) Total Ankle SystemsWrightmedicaltechnologyinc · 2013
  6. Descendant · cites it directly · 17 of its ownK141740 Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc · 2015
  7. Descendant · 2 generations on · 13 of its ownK171067 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017
  8. Descendant · 3 generations on · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
  9. Descendant · 3 generations on · 3 of its ownK180730 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2018
  10. Descendant · 4 generations on · 2 of its ownK210390 Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2015: 12017: 22018: 32019: 12020: 32021: 22022: 12023: 22024: 32025: 22026: 1
2015high 3 (2018) · low 0 (2016)2026

Most influential descendants

Showing 5 of 21 · See all
  • K141740Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc · 2015 · cites it directly17descendants
  • K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017 · 2 generations on13descendants
  • K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020 · 3 generations on8descendants
  • K180730INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2018 · 3 generations on3descendants
  • K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K920802Alvine Total AnkleDepuy, Inc.1992—
−3K020541Agility Ankle Revision ProsthesisDepuy, Inc.2002—
−2K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc.20054
−1K100886Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc20102
0 (this device)K123059Inbone ( I and II) Total Ankle SystemsWrightmedicaltechnologyinc2013—
+1K141740Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc2015—
+2K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc2017—
+3K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2020—
+3K180730INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc2018—
+4K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201720
201830
201910
202030
202120
202210
202320
202430
202520
202610
FIG. 1 — Lineage of K123059, 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 16.7 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K051023Topez Total Ankle Replacement
Summary page 1
…me and Reference: 21 CFR 888.3110 - Class II Device Product Code, Device Panel: HSN: Orthopedic (a)(3). Predicate Device: K05 1023 INBONE® Total Ankle K 103374 INBONE® Total Ankle…
Topez Orthopedics, Inc.20054
*K103374Inbone Total Ankle System Model 200347902
Summary page 1
…, Device Panel: HSN: Orthopedic (a)(3). Predicate Device: K05 1023 INBONE® Total Ankle K 103374 INBONE® Total Ankle K100886 INBONE® 11 Total Ankle (a)(4). Device Description…
Wrightmedicaltechnologyinc2010—
*K100886Inbone II Total Ankle Replacement
Summary page 1
…K05 1023 INBONE® Total Ankle K 103374 INBONE® Total Ankle K100886 INBONE® 11 Total Ankle (a)(4). Device Description The INBONE® implant is a total ankle replacement (TAR) that is made of…
Wrightmedicaltechnologyinc20102

Also cleared against K051023: 8 other devices →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K141740Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc201517
K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC20172
K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190

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 21 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K141740 (Wrightmedicaltechnologyinc, 2015) has gone furthest, with 17 descendants of its own.
  • 8 other devices also cite its predicate K051023.

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. 2013, 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 INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe

rheumatoid, post-traumatic, or degenerative arthritis.

The INBONE® 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.

Also cleared against K051023

8 other devices cite the same predicate.

  • K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017
  • K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016
  • K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 201319 recalls
  • K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc · 20132 recalls
  • K110360Prophecy Inbone Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2011
  • K100886Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 20102 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/K123059 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123059: Inbone ( I and II) Total Ankle Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123059

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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