510(k) · Cleared
ClearedDynaNail TTC Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MedShape, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Sep 12, 2025 as substantially equivalent to K171376 (MedShape, Inc., 2017) after a 193-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Sep 12, 2025
- Review
- 193 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K974781 (1998). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK974781 Depuy Ace Aim (R) Titanium Supracondylar NailDepuy, Inc. · 1998
- 4 generations backK023115 Ace VersanailDePuy Orthopaedics, Inc. · 2002
- 3 generations backK101934 Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail…Medshape Solutions · 2011
- 2 generations backK113828 Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012
- 1 generation backK171376 DynaNail TTC Fusion SystemMedShape, Inc. · 2017
- This deviceK250628 DynaNail TTC Fusion SystemMedShape, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974781 | Depuy Ace Aim (R) Titanium Supracondylar Nail | Depuy, Inc. | 1998 | — |
| −4 | K023115 | Ace Versanail | DePuy Orthopaedics, Inc. | 2002 | — |
| −3 | K101934 | Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models… | Medshape Solutions | 2011 | — |
| −2 | K113828 | Dynanail Ankle Arthrodesis Nail | MedShape, Inc. | 2012 | — |
| −1 | K171376 | DynaNail TTC Fusion System | MedShape, Inc. | 2017 | — |
| 0 (this device) | K250628 | DynaNail TTC Fusion System | MedShape, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171376 | DynaNail TTC Fusion SystemSummary page 5…nt in intended use and fundamental scientific technology to its predicate device MedShape, Inc.’s DynaNail TTC Fusion System cleared under 510(k) K171376 on 11/02/2017. The reference devices are Paragon 28 Inc.’s Phantom® Hindfoot TTC/TC Nail System cleared under 510(k)… | 2017 |
| † | K251850 | Phantom® Hindfoot TTC/TC Nail System | 2025 |
| † | K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant System | 2022 |
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 27 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 6 other devices also cite its predicate K171376.
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. 2025, 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 DynaNail TTC Fusion System is intended for use in tibiotalocalcaneal fusions:
* Post-traumatic and degenerative arthritis.
* Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
* Revision after failed ankle arthrodesis with subtalar involvement.
* Failed total ankle arthroplasty.
* Non-union ankle arthrodesis.
* Rheumatoid hindfoot.
» Absent Talus (requiring tibiocalcaneal arthrodesis).
» Avascular necrosis of the talus.
* Neuroarthropathy or neuropathic ankle deformity.
* Neuromuscular disease and severe deformity.
* Osteoarthritis.
* Charcot Foot.
* Previously infected arthrosis, second degree.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250628: DynaNail TTC Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250628
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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