510(k) · Cleared
ClearedTRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones Sas · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 15, 2018 as substantially equivalent to K091788 (Newdeal Sas, 2009) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.
- Decided
- Mar 15, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K982953 (1998). 10 ancestors in all, the oldest K974781 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 3 generations backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
- 2 generations backK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled
- 1 generation backK091788 Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · Recalled
- This deviceK173811 TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas · 2018
- Descendant · cites it directly · 0 of its ownK250622 Succession™ AFN SystemOrtho Solutions UK, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250622Succession™ AFN SystemOrtho Solutions UK, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | 4 |
| −3 | K021786 | Titanium Ankle Arthrodesis Nail | Biomet, Inc. | 2002 | 1 |
| −2 | K050882 | Newdeal Ankle Nail | New Deal, S.A. | 2005 | 5 |
| −1 | K091788 | Panta Nail (Dia. 10MM), Panta Nail XL | Newdeal Sas | 2009 | 2 |
| 0 (this device) | K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | In2bones Sas | 2018 | — |
| +1 | K250622 | Succession™ AFN System | Ortho Solutions UK, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 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? (2)
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 |
|---|---|---|---|
| * | K091788 | Panta Nail (Dia. 10MM), Panta Nail XLSummary page 5…: The TRIWAY® TTC Arthrodesis System is supplied sterile, using gamma irradiation. Predicate Primary Predicate: Devices Panta Nail (K091788), Newdeal, Acquired by Integra LifeSciences Additional Predicate: T2 Ankle Arthrodesis Nail… | 2009 |
| * | K051590 | T2 Ankle Arthrodesis NailSummary page 5…: Devices Panta Nail (K091788), Newdeal, Acquired by Integra LifeSciences Additional Predicate: T2 Ankle Arthrodesis Nail (K051590), Stryker Indications for The TRIWAY® TTC Arthrodesis System is intended for use in use tibiotalocalcaneal arthr… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250622 | Succession™ AFN System | 2025 | 0 |
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 20 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K250622 (Ortho Solutions UK, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K091788.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The TRIWAY® TTC Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: • Post-traumatic and degenerative arthritis involving both ankle and subtalar joints • Rheumatoid arthritis with severe deformity • Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body • Revision of failed total ankle arthroplasty with subtalar…
Read the full statement (129 words)
The TRIWAY® TTC Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:
• Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
• Rheumatoid arthritis with severe deformity
• Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
• Revision of failed total ankle arthroplasty with subtalar intrusion
• Talar deficiency conditions, including avascular necrosis (requiring a tibiocalcaneal arthrodesis)
• Neuroarthropathy or neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle, including Charcot foot
• Severe pilon fractures with trauma to the subtalar joint
• Malunited tibial pilon fractures
The addition of an IBS™ 6.5mm compression screw through the subtalar joint and through the nail is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173811: TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173811
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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