510(k) Report

510(k) · Cleared

Cleared

Quantum® Total Ankle Prosthesis

K191380510(k) TraditionalCleared Jan 29, 2020251-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

In2bones Sas · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Jan 29, 2020 as substantially equivalent to K090076 (Tornier, 2009) and 3 other predicates after a 251-day review. Its family tree reaches back 7 generations to 1992.

Decided
Jan 29, 2020
Review
251 days
Class
Class II
Product code
HSN
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K920802 (1992). 25 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2016: 1 other ancestor2015: 1 other ancestor2009: 1 other ancestor2013: 1 other ancestor2006: 3 other ancestors2010: 1 other ancestor2005: 1 other ancestor2002: 2 other ancestors2000: 2 other ancestors2004: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestor1995: 1 other ancestorK920802 · 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 · recalledK140749 · Infinity Total Ankle System · Wrightmedicaltechnologyinc · 2014 · recalledK152217 · Exactech Vantage Total Ankle System · Exactech, Inc. · 2016 · recalled1990199520002005201020152020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 6 other ancestors4 generations back: 5 other ancestors5 generations back: 2 other ancestors K152217 · Exactech Vantage Total Ankle System · Exactech, Inc. · 2016 · recalledK140749 · Infinity Total Ankle System · Wrightmedicaltechnologyinc · 2014 · recalledK123954 · 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
  1. Root · 7 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
  2. 6 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
  3. 5 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
  4. 4 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
  5. 3 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
  6. 2 generations backK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
  7. 1 generation backK152217 Exactech Vantage Total Ankle SystemExactech, Inc. · 2016 · Recalled
  8. This deviceK191380 Quantum® Total Ankle ProsthesisIn2bones Sas · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K920802Alvine Total AnkleDepuy, Inc.1992—
−6K020541Agility Ankle Revision ProsthesisDepuy, Inc.2002—
−5K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc.20054
−4K100886Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc20102
−3K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc20132
−2K140749Infinity Total Ankle SystemWrightmedicaltechnologyinc20141
−1K152217Exactech Vantage Total Ankle SystemExactech, Inc.20166
0 (this device)K191380Quantum® Total Ankle ProsthesisIn2bones Sas2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810
199920
200020
200220
200410
200510
200630
200910
201010
201310
201510
201610
FIG. 1 — Lineage of K191380, 1992–2020Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K090076Salto Talaris Total Ankle Prosthesis
Summary page 5
…te: In the United States, the ankle prosthesis is intended for cement use only. Predicate Primary predicate: Devices - Salto Talaris (K090076 & K153452), Tornier Additional predicates: - Cadence / Integra Total Ankle Replacement System…
Tornier200918
*K153452Salto XT, Salto Talaris
Summary page 5
…United States, the ankle prosthesis is intended for cement use only. Predicate Primary predicate: Devices - Salto Talaris (K090076 & K153452), Tornier Additional predicates: - Cadence / Integra Total Ankle Replacement System (K151459)…
Tornier S.A.S.20168
*K151459Integra Total Ankle Replacement System
Summary page 5
…ces - Salto Talaris (K090076 & K153452), Tornier Additional predicates: - Cadence / Integra Total Ankle Replacement System (K151459), Ascension Orthopedics (acquired by Integra LifeSciences) - Vantage (K152217), Exactech Comp…
Ascension Orthopedics20152
*K152217Exactech Vantage Total Ankle System
Summary page 5
…- Cadence / Integra Total Ankle Replacement System (K151459), Ascension Orthopedics (acquired by Integra LifeSciences) - Vantage (K152217), Exactech Comparison of The In2Bones QUANTUM® total ankle prosthesis is similar to the Indications and predicate devices S…
Exactech, Inc.20166

Also cleared against K090076: 4 other devices →

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 28 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
  • 16 of the 25 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K090076.

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. 2020, 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 Quantum® total ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

Note: In the United States, the ankle prosthesis is intended for cement use only.

Indications for use as stated in the FDA summary.

Also cleared against K090076

4 other devices cite the same predicate.

  • K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017
  • K153452Salto XT, Salto TalarisTornier S.A.S. · 20168 recalls
  • K152217Exactech Vantage Total Ankle SystemExactech, Inc. · 20166 recalls
  • K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 201319 recalls

More from In2bones Sas

18 FDA decisions under this applicant name. See the company

  • K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2024
  • K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2023
  • K211883QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2021
  • K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas · 2018
  • K173616DIP Arthrodesis SystemIn2bones Sas · 2018

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The HSN category page

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https://510kreport.com/device/K191380 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191380: Quantum® Total Ankle Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191380

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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