510(k) Report

510(k) · Cleared

Cleared

DynaNail TTC Fusion System

K171376510(k) TraditionalCleared Nov 2, 2017176-day reviewClass II21 CFR 888.3020

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

MedShape, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Nov 2, 2017 as substantially equivalent to K101934 (Medshape Solutions, 2011) and 1 other predicate after a 176-day review. Its family tree reaches back 4 generations to 1998. 22 later devices descend from it.

Decided
Nov 2, 2017
Review
176 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K974781 (1998). 8 ancestors in all. 22 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors2025: 3 descendants cleared2019: 3 descendants cleared2020: 4 descendants cleared2022: 2 descendants cleared2023: 2 descendants cleared2021: 2 descendants cleared2026: 4 descendants cleared2024: 2 descendants clearedK974781 · Depuy Ace Aim (R) Titanium Supracondylar Nail · Depuy, Inc. · 1998K023115 · Ace Versanail · DePuy Orthopaedics, Inc. · 2002K101934 · Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000 · Medshape Solutions · 2011K113828 · Dynanail Ankle Arthrodesis Nail · MedShape, Inc. · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 4 other ancestors 1 generation forward: 7 descendants2 generations forward: 8 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant K113828 · Dynanail Ankle Arthrodesis Nail · MedShape, Inc. · 2012K101934 · Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000 · Medshape Solutions · 2011K023115 · Ace Versanail · DePuy Orthopaedics, Inc. · 2002K974781 · Depuy Ace Aim (R) Titanium Supracondylar Nail · Depuy, Inc. · 19980
  1. Root · 4 generations backK974781 Depuy Ace Aim (R) Titanium Supracondylar NailDepuy, Inc. · 1998
  2. 3 generations backK023115 Ace VersanailDePuy Orthopaedics, Inc. · 2002
  3. 2 generations backK101934 Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail…Medshape Solutions · 2011
  4. 1 generation backK113828 Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012
  5. This deviceK171376 DynaNail TTC Fusion SystemMedShape, Inc. · 2017
  6. Descendant · cites it directly · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
  7. Descendant · cites it directly · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
  8. Descendant · 2 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
  9. Descendant · 2 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
  10. Descendant · cites it directly · 5 of its ownK182677 DynaNail MiniMedShape, Inc. · 2019

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2019: 32020: 42021: 22022: 22023: 22024: 22025: 32026: 4
2019high 4 (2020) · low 2 (2021)2026

Most influential descendants

Showing 5 of 22 · See all
  • K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · cites it directly8descendants
  • K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · cites it directly6descendants
  • K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on6descendants
  • K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 2 generations on5descendants
  • K182677DynaNail MiniMedShape, Inc. · 2019 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K974781Depuy Ace Aim (R) Titanium Supracondylar NailDepuy, Inc.1998—
−3K023115Ace VersanailDePuy Orthopaedics, Inc.2002—
−2K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models…Medshape Solutions2011—
−1K113828Dynanail Ankle Arthrodesis NailMedShape, Inc.2012—
0 (this device)K171376DynaNail TTC Fusion SystemMedShape, Inc.2017—
+1K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…Paragon 28, Inc.2019—
+1K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.2020—
+2K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.2019—
+2K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.2020—
+1K182677DynaNail MiniMedShape, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201930
202040
202120
202220
202320
202420
202530
202640
FIG. 1 — Lineage of K171376, 1998–2026Source: 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 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. #1 K200869 Gamma3 Systemscore 19.8 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…
Summary page 4
…ramedullary Fixation Rod HSB 21 CFR 888.3020 E. Predicate Device(s): DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K101934 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K113828 F. Physical Description: The proposed DynaNa…
Medshape Solutions2011—
*K113828Dynanail Ankle Arthrodesis Nail
Summary page 4
…888.3020 E. Predicate Device(s): DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K101934 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K113828 F. Physical Description: The proposed DynaNail™ is a sterile, single use titanium device with an additi…
MedShape, Inc.2012—

Also cleared against K101934: 2 other devices →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198
K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206
K182677DynaNail MiniMedShape, Inc.20195
K200430Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20203
K250628DynaNail TTC Fusion SystemMedShape, Inc.20250
K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250
K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc.20220

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 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K182307 (Paragon 28, Inc., 2019) has gone furthest, with 8 descendants of its own.
  • 2 other devices also cite its predicate K101934.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The DynaNail TTC Fusion System is intended for tibio-talo-calcaneal 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 as stated in the FDA summary.

Also cleared against K101934

2 other devices cite the same predicate.

  • K182677DynaNail MiniMedShape, Inc. · 2019
  • K113828Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012

More from MedShape, Inc.

17 FDA decisions under this applicant name. See the company

  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroMedShape, Inc. · 2026
  • K250628DynaNail TTC Fusion SystemMedShape, Inc. · 2025
  • K240530DynaNail Mini Tapered HybridMedShape, Inc. · 2024
  • K220812DynaClip® Bone StapleMedShape, Inc. · 2022

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K171376 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171376: 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/K171376

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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